A Phase I Study to Evaluate the Short-term Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution With 30% Icodextrin and 10% Dextrose in Patients in Peritoneal Dialysis, on a Preliminary Basis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Tolerability defined as pain in a scale from 0 to 4 during infusion, dwell, and drain
研究概览
简要总结
This study will evaluate the safety and tolerability profile of a dwell time (bath) of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose in patients with chronic kidney failure undergoing peritoneal dialysis
详细描述
Phase I clinical trial which will include ten patients currently undergoing chronic peritoneal dialysis treatment. Patients will be hospitalized for the study. The study will consist of replacing conventional peritoneal dialysis solution with a sodium-free 500 ml solution with 30% icodextrin and 10% dextrose with a dwell time of 24 hours.
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
- •Patients covered by the Mexican Social Security Department.
- •Adults over the age of eighteen.
- •Patients with chronic kidney failure undergoing replacement therapy with peritoneal dialysis.
- •Patients with a functional peritoneal dialysis catheter.
- •Patients undergoing peritoneal dialysis that was stable in the most recent month (ongoing peritoneal dialysis as an outpatient or ongoing cyclic peritoneal dialysis)
- •Patients who wish to participate and who sign the informed consent.
- •If the peritoneal dialysis catheter and the transfer line are compatible with the peritoneal dialysis bag that has a simple luer male connector.
- •If treating doctors consider their patient to be clinically euvolemic.
- •If patients have undergone a peritoneal equilibrium test and their dialysis prescription has not been changed since the test was carried out
- •Exclusion criteria:
- •Diabetes mellitus type 1 or uncontrolled diabetes (a1c hemoglobin greater than 8%).
- •Active infection.
- •Serum sodium prior to the study less than 130 mmol/l.
- •Serum bicarbonate prior to the study less than 18 mmol/l.
- •Patients who have been prescribed standard peritoneal dialysis who only use solutions with the lowest amount of dextrose
- •Hemoglobin less than 8 g/dl.
- •Active bleeding.
- •Patients prescribed peritoneal dialysis who use a 4.25% dextrose solution at least once a day.
- •Patients with a membrane defect or mechanical defect.
- •Diastolic dysfunction with an increase in filling pressure according to the echocardiogram.
- •Patients with active or suspected peritonitis according to the clinical criterion or their treating doctor.
排除标准
- 未提供
研究组 & 干预措施
30% icodextrin and 10% dextrose
Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose
干预措施: 30% icodextrin and 10% dextrose (Drug)
结局指标
主要结局
Tolerability defined as pain in a scale from 0 to 4 during infusion, dwell, and drain
时间窗: During the 24 hour dwell
Description of pain. Pain will be described in a scale from 0 to 4; 0 is no pain, 1 is mild pain, 2 is moderate pain, 3 is severe pain, and 4 is extreme pain. Pain will be assessed during infusion, then hourly during the 24 hour dwell, and during the draining
Safety defined as the number serious adverse events related to the investigational product
时间窗: During the 24 hour dwell
Safety will be described based on the number of serious adverse events that are determined to be related to the investigational product
次要结局
- Sodium excretion with ultrafiltration(During the 24 hour dwell)
- Ultrafiltration(During the 24 hour dwell)
研究者
Eduardo Almeida Gutiérrez
Head of Research and Education at Hospital de Cardiologia
Instituto Mexicano del Seguro Social