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临床试验/NCT06314503
NCT06314503招募中不适用

Clinical Validation of a Continuous Flow Peritoneal Dialysis System With Dialysate Regeneration

UMC Utrecht6 个研究点 分布在 3 个国家目标入组 12 人开始时间: 2024年1月22日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
UMC Utrecht
入组人数
12
试验地点
6
主要终点
Critical changes in plasma calcium
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid.

The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment.

The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions.

Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber.

Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane).

详细描述

Peritoneal dialysis (PD) is a life-sustaining renal replacement therapy for patients with end-stage kidney disease (ESKD). With PD, waste solutes and excess water are drawn from the blood across the peritoneal membrane lining the abdominal cavity via diffusion and osmosis, respectively, into dialysis fluid (peritoneal dialysate) that is introduced into the abdominal cavity through a permanent tube (peritoneal catheter). The peritoneal dialysate is replaced 4-6 times/day either manually by the patient or automatically by a machine at night while the patient is asleep. PD is a gentle dialysis technique that provides continuous gradual dialysis while the patient is free to move during the day. However, PD has several disadvantages. Removal of waste solutes is inadequate and technique failure rate is high, contributing to poor quality of life and high (co)morbidity and mortality (10-15% per year). The low solute clearance (~1-7% of that of healthy kidneys (depending on the solute) and lower than that with haemodialysis (HD)) is due to rapid decrease of diffusive transport of solutes during a dwell due to the disappearance of the plasma-to-dialysate concentration gradient across the peritoneal membrane. The limited technique survival (median 3.7 years) is primarily due to the high incidence of recurrent infection of the peritoneal membrane (peritonitis) and exposure of the peritoneal membrane to very high, harmful glucose concentrations needed for osmotic fluid removal.

Both peritonitis and high glucose concentrations cause pathological changes of the peritoneal membrane and eventually ultrafiltration failure necessitating a switch to the more invasive and expensive HD treatment. To reduce the existing shortcomings of conventional PD, a novel continuous flow peritoneal dialysis system with dialysate regeneration (WEAKID) for PD was developed. WEAKID treatment is based on continuous recirculation of peritoneal dialysate via the single lumen peritoneal catheter with regeneration of spent dialysate by means of sorbent technology. The WEAKID nighttime system (weight: ~12 kg) is intended to be used for 8h per day (during the night) on a daily basis. Instead of performing 4-6 exchanges with fresh peritoneal dialysate per day, WEAKID uses one peritoneal dialysate filling which is continuously recirculated and regenerated. The continuous regeneration prevents saturation of the dialysate with toxins and thereby maintains a high plasma to dialysate concentration gradient which enhances diffusive transport of uremic toxins. In addition, the continuous recirculating flow of fluid along the peritoneal membrane is expected to increase the mass transfer area coefficient as observed in previous studies with continuous flow peritoneal dialysis, probably due to reduction of diffusion resistance, renewal of stagnant fluid layers at the tissue surface and an increase of the effective membrane area. Both the high plasma to dialysate concentration gradient and the increase in mass transfer contribute to an enhancement of the clearance. Another advantage of the WEAKID system is that the glucose peak load to peritoneum is lower than with traditional automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD) thanks to the buffering of the sorbents (sorbents adsorb glucose at the start, lowering the initial glucose peak, and release the glucose again at later stage) and the continuous recirculation.

The primary objective of this study is to assess the (short-term) safety of the WEAKID nighttime system in a limited number (n=12) of patients and sessions (6 sessions per patient).

Secondary objectives of this study are:

  1. To evaluate the incidence of adverse events (AEs) and device deficiencies (DDs) other than serious adverse device effects (SADEs) and DDs that could have led to a serious adverse event (SAE)
  2. To describe the characteristics of WEAKID treatment (i.e. number and duration of sessions, dialysate flow rates)
  3. To evaluate the clinical condition and vital signs of the participants during WEAKID treatment
  4. To evaluate the effectiveness of ultrafiltration (UF) in relation to glucose concentration during WEAKID treatment
  5. To evaluate the efficacy of solute removal and base release of WEAKID treatment
  6. To evaluate the evolution of plasma analytes during WEAKID treatment
  7. To evaluate the evolution of dialysate effluent analytes of the WEAKID system
  8. To evaluate the (technical) device performance of the WEAKID system by the number of device deficiencies, adverse device effects and changes in intraperitoneal pressure
  9. To evaluate patient tolerance during WEAKID treatment
  10. To evaluate the evolution of uremic symptoms during WEAKID treatment
  11. To evaluate the effectiveness of using sorbents for dialysate regeneration and the effectiveness of continuous recirculating flow in relation to the efficacy of solute removal.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •≥18 years of age
  • •Treated with PD for at least 3 months prior to enrolment
  • •Well-functioning peritoneal catheter and no peritoneal catheter replacement for at least a month prior to enrolment
  • •No PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the treatment has been finished).
  • •Previous or current use of Extraneal® with no contra-indications
  • •Capable of understanding the patient information sheet and informed consent form (ICF) and give informed consent
  • •Willing and able to comply with all study procedures and attend all study visits

排除标准

  • •Patients who are unable to provide informed consent
  • •Patients who are unable to comply with study procedures
  • •Patients who received renal replacement therapy other than conventional PD less than 8 weeks prior to enrolment
  • •Patients who participated in an intervention trial less than 8 weeks prior to enrolment or are currently participating in an intervention trial. Patients in an observational study without any interventions or in post-market surveillance do not need to be excluded.
  • •Patients with a PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the treatment has been finished)
  • •Patients with peritoneal catheter dysfunction or mechanical issues less than one month prior to enrolment
  • •Patients who have never used Extraneal® dialysis fluid or have a contra-indication for Extraneal®: a known allergy to cornstarch or icodextrin; maltose or isomaltose intolerance; glycogen storage disease
  • •Patients with an incompatible PD connection to the device (e.g. Fresenius PD system)
  • •Patients with haemoglobin concentrations < 6.2 mmol/L (< 10 g/dL) less than 8 weeks prior to enrolment
  • •Patients with hyperkalemia (> 6.0 mmol/L) or hyponatremia (< 130 mmol/L) in the 8 weeks prior to enrolment
  • •Patients with hypocalcemia (plasma total calcium concentration corrected for albumin <2.20 mmol/L or ionized calcium <1.15 mmol/L) or hypomagnesemia (plasma magnesium concentration <0.70 mmol/L) in the 8 weeks prior to enrolment
  • •Patients with any serious medical condition which in the opinion of the investigator, may adversely affect the safety of the participant and/or effectiveness of the study
  • •Female patients who are either (planning to become) pregnant within the study period or breast feeding
  • •Patients with a life expectancy <3 months
  • •Anticipated living donor kidney transplantation <3 months

研究组 & 干预措施

WEAKID

Experimental

Six treatments over the course of two weeks with the WEAKID system

干预措施: WEAKID (Device)

结局指标

主要结局

Critical changes in plasma calcium

时间窗: This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

Critical changes requiring intervention in plasma calcium (before and after WEAKID treatment in mmol/L).

Critical changes in intra-abdominal dialysate volume

时间窗: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

Critical changes requiring intervention in intra-abdominal dialysate volume.

Critical changes in blood pressure

时间窗: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

Critical changes requiring intervention in blood pressure (measured in mmHg; both systolic and diastolic pressures will be assessed).

Critical changes in heart rate

时间窗: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

Critical changes requiring intervention in heart rate (measured in beats per minute).

Critical changes in oxygen saturation

时间窗: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

Critical changes requiring intervention in oxygen saturation (measured in %).

Critical changes in plasma bicarbonate

时间窗: This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

Critical changes requiring intervention in plasma bicarbonate (before and after WEAKID treatment in mmol/L).

Critical changes in intra-abdominal pressure

时间窗: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

Critical changes requiring intervention in intra-abdominal dialysate pressure (in mbar).

Critical changes in plasma potassium

时间窗: This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

Critical changes requiring intervention in plasma potassium (before and after WEAKID treatment in mmol/L).

Serious adverse device effects (SADEs) and device deficiencies (DDs)

时间窗: This will be assessed through study completion (four weeks in total per participant)

Serious adverse device effects (SADEs) and device deficiencies (DDs) that could have led to a serious adverse event

Critical changes in body temperature

时间窗: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)

Critical changes requiring intervention in body temperature (measured in °C).

次要结局

  • Plasma clearance of phosphate(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Plasma clearance of beta-2 microglobulin(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of creatinine(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of uric acid(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of beta-2 microglobulin(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of phosphate(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of potassium(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of bicarbonate(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of lactate(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of sodium(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin p-cresyl sulfate(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of chloride(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of calcium(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin p-cresyl glucuronide(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of magnesium(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of glucose(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin indole acetic acid(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin kynurenine(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin kynurenic acid(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin hippuric acid(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The release of base(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of urea(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Peak glucose concentration in the device effluent(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Ultrafiltration efficiency(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Removal of urea by the WEAKID system(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Removal of creatinine by the WEAKID system(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Adverse events (AEs) and device deficiencies (DDs)(This will be assessed through study completion (four weeks in total per participant))
  • Number of WEAKID treatments(The number of WEAKID treatments will be assessed for the study treatment period (2 weeks in total per participant))
  • Dialysate flow rates during WEAKID treatment(This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of blood pressure(This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of heart rate(This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of body temperature(This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Removal of phosphate by the WEAKID system(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Removal of potassium by the WEAKID system(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Removal of beta-2 microglobulin by the WEAKID system(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Mass transfer area coefficient of urea(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Mass transfer area coefficient of creatinine(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Mass transfer area coefficient of phosphate(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Mass transfer area coefficient of beta-2 microglobulin(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Plasma clearance of urea(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Plasma clearance of creatinine(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of lactate dehydrogenase(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of vitamin B12(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of albumin(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma leucocyte count(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma thrombocyte count(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of C-reactive protein (CRP)(This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant))
  • Evolution of plasma levels of bilirubin(This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant))
  • Evolution of plasma levels of alanine aminotransferase (ALAT)(This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant))
  • Evolution of sodium levels in dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of chloride levels in dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of calcium levels in dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of magnesium levels in dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of pH of dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of delta intraperitoneal pressure during WEAKID treatment(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of uremic symptoms(This will be assessed at baseline and on the day of the last WEAKID treatment of each treatment week (three times during three weeks in total per participant).)
  • Adverse events (AEs) and device deficiencies (DDs)(This will be assessed through study completion (four weeks in total per participant))
  • Number of WEAKID treatments(The number of WEAKID treatments will be assessed for the study treatment period (2 weeks in total per participant))
  • Duration of WEAKID treatments(This will be assessed for each WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Dialysate flow rates during WEAKID treatment(This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of blood pressure(This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of heart rate(This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of body temperature(This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Removal of beta-2 microglobulin by the WEAKID system(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of oxygen saturation(This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Ultrafiltration volume(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Peak glucose concentration in the device effluent(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Ultrafiltration efficiency(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Removal of urea by the WEAKID system(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Removal of creatinine by the WEAKID system(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Removal of phosphate by the WEAKID system(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Removal of potassium by the WEAKID system(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Mass transfer area coefficient of urea(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Mass transfer area coefficient of creatinine(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Mass transfer area coefficient of phosphate(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Mass transfer area coefficient of potassium(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Mass transfer area coefficient of beta-2 microglobulin(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Plasma clearance of urea(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Plasma clearance of creatinine(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of uric acid(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of beta-2 microglobulin(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Plasma clearance of phosphate(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Plasma clearance of potassium(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of phosphate(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Plasma clearance of beta-2 microglobulin(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin p-cresyl sulfate(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin p-cresyl glucuronide(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin indole acetic acid(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin kynurenine(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin kynurenic acid(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The plasma reduction ratio of the protein-bound uremic toxin hippuric acid(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • The release of base(This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of urea(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of creatinine(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of potassium(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of bicarbonate(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of lactate(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of sodium(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of chloride(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of calcium(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of magnesium(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of glucose(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of lactate dehydrogenase(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of vitamin B12(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of albumin(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma leucocyte count(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma thrombocyte count(These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant))
  • Evolution of plasma levels of C-reactive protein (CRP)(This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant))
  • Evolution of plasma levels of bilirubin(This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant))
  • Evolution of plasma levels of aspartate transaminase (ASAT)(This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant))
  • Evolution of plasma levels of alanine aminotransferase (ALAT)(This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant))
  • Evolution of sodium levels in dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of chloride levels in dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of calcium levels in dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of magnesium levels in dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of bicarbonate levels in dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of lactate levels in dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Evolution of pH of dialysate effluent(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Total number of device deficiencies and adverse device effects(This will be assessed through study completion (four weeks in total per participant))
  • Evolution of delta intraperitoneal pressure during WEAKID treatment(This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant))
  • Patient tolerance (abdominal discomfort)(This will be assessed at baseline, during every WEAKID treatment (at t = 0 minutes, 15 minutes, 1 hour, 2 hours, 4 hours, and 8 hours (for 8-hour treatment), and at the end of the study period (4 weeks in total per participant).)
  • Evolution of uremic symptoms(This will be assessed at baseline and on the day of the last WEAKID treatment of each treatment week (three times during three weeks in total per participant).)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karin G.F. Gerritsen

MD, PhD, Associate professor

UMC Utrecht

研究点 (6)

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