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临床试验/NCT04522635
NCT04522635已完成4 期

Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury

University of California, San Diego0 个研究点目标入组 65 人开始时间: 2015年6月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
65
主要终点
fluid removal

研究概览

简要总结

Hospitalized patients often suffer from an acute shutdown of kidney function secondary to infections, use of antibiotics, or use of intravenous contrast agents. This results in the accumulation of toxic substances and retention of fluid in the body. Dialysis techniques are often needed to manage these patients to remove the retained toxic substances and extra fluid and allow the kidney time to recover. The amount and duration of fluid accumulation have been associated with a higher risk of death and longer hospital stays. Correction of fluid overload with dialysis has been shown to be beneficial in improving the outcomes from these patients. Most patients are quite sick and often have low levels of a blood protein called albumin that makes them more prone to developing low blood pressure during dialysis and limits the ability of dialysis to remove solutes and fluid adequately. Often dialysis sessions are complicated by the development of low blood pressures and symptoms such as nausea, vomiting, and headaches that further compromises dialysis efficacy. In this study, the hypothesis that addition of intravenous albumin during the dialysis session will improve the ability to remove fluid and reduce the incidence of low blood pressure during dialysis thereby improving patient tolerance and the efficacy of the procedure will be tested. Patients with acute kidney failure or end-stage Renal Disease who need dialysis for fluid removal will be allocated to receive albumin or saline as intravenous fluids during individual dialysis sessions and information on how much fluid can be removed and how many complications occur in each session will be recorded. Dialysis sessions with albumin will be compared with those with saline alone to determine the benefit of adding albumin to the treatment. Information obtained from this study will allow physicians to manage patients requiring dialysis for acute kidney failure more effectively and help improve outcomes.

详细描述

This study will address the following questions:

AIM 1: Can the utilization of intravenous albumin enhance the efficacy of fluid removal in hospitalized patients undergoing dialysis for AKI or ESRD.

The hypothesis to be tested:

  1. Addition of albumin solutions to dialysis therapy will enhance the efficacy of fluid removal (total amount of fluid removed)
  2. Albumin solutions will improve the efficiency of fluid removal by dialysis per unit time
  3. Albumin addition will reduce the time to achieving and maintaining fluid balance and correcting fluid overload.

AIM 2: Can the utilization of IV albumin improve the safety of fluid removal during dialysis?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • age > 18 years old
  • need for intermittent hemodialysis during hospitalization
  • hypoalbuminemia (albumin<3g/dl)

排除标准

  • allergy to the components of albumin

研究组 & 干预措施

albumin

Active Comparator

albumin (100 ml of Grifols 25%) given intravenously at the start of IHD

干预措施: (100 ml of Albumin 25%) (Drug)

normal saline

Placebo Comparator

0.9% sodium chloride (normal saline (NS)) given intravenously at the start of IHD

干预措施: (100 ml of Albumin 25%) (Drug)

结局指标

主要结局

fluid removal

时间窗: during procedure

achieved fluid removal expressed as ml/kg/hour

次要结局

  • hypotension(during procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ravindra Mehta

Professor Emeritus

University of California, San Diego

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