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临床试验/CTRI/2021/12/039048
CTRI/2021/12/039048已完成不适用

Effect of Individualized Dialysate Sodium for maintenance hemodialysis patients in tertiary hospital

KEM Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
KEM Hospital
入组人数
48
试验地点
1
主要终点
Weight gain between two dialysis sessions

研究概览

简要总结

Dialysate, i.e. fluid which is used for dialysis has sodium as an important constituent. The level of dialysate sodium determines various aspects of the dialysis session such as blood pressure, thirst after dialysis and the weight gain between two dialysis sessions. Currently,all patients undergoing dialysis worldwideare dialyzed with dialysate sodium which is arbitrarily set, irrespective oftheir blood sodium levels. A dialysatesodium concentration higher than the patient’s own blood sodium level can contribute to increased thirst, weight gain in between the dialysis and increasein blood pressure. Using individualized dialysate sodium is thought to avoid addition of excess sodium and water to the patient’s body.

In this study we aim to study the effect of individualizing the dialysate sodium (near to the patient’s blood sodium levels) on weight gain between two dialysis sessions, blood pressure before dialysis, requirement of blood-pressure-lowering medications and also on the blood pressure during dialysis.

We are randomizing the participants based on a fixed protocol to either receive individialized dialysate sodium (2 mEq above patient’s own blood sodium levels) or to receive standard dialysate sodium of 136 mEq/L- which is current standard of care. After 1 month, the patient will switch the groups and will receive the other group’s sodium level in the dialysis fluid. The monitoring will be done to see weight gains between two dialysis sessions in both groups.

As a close monitoring is always done during the hemodialysis session, risk to the participants is less. All fluctuations in blood pressure in both arms of the study will be dealt with using standard protocols.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Chronic kidney disease stage 5D patients on maintenance hemodialysis
  • Achieved dry weight as per clinical or bio-impedence estimation, with minimal manipulation.

排除标准

  • Patients dialyzing less than 3/week 2)Life expectancy < 6 months 3)Failure to consent.

结局指标

主要结局

Weight gain between two dialysis sessions

时间窗: 3 months

次要结局

  • Change in systolic blood pressure before the hemodialysis session(2 months)
  • Episodes of hypotension or hypertension during dialysis(2 months)
  • Change in the requirement of BP medicines(2 months)

研究者

发起方
KEM Hospital
申办方类型
Private hospital/clinic

研究点 (1)

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