NL-OMON53288招募中不适用
Clinical Validation of a Continuous flow Peritoneal Dialysis System with Dialysate Regeneration - CORDIA
niversitair Medisch Centrum Utrecht0 个研究点目标入组 4 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •>=18 years of age.
- •Treated with peritoneal dialysis 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.
- •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
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 which, in the
- •opinion of the investigator, may adversely affect the safety of the participant
- •and/or effectiveness of the study. Patients in an observational study without
- •any interventions or in post-market surveillance do not need to be excluded.
- •Patients with PD related infection (exit-site infection, tunnel infection or
- •peritonitis) less than 8 weeks prior to enrolment.
- •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®:
- •Patients with an incompatible PD connection to the device (e.g. Fresenius PD
- •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.
研究者
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