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Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury

NCT04522635 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-08-24

No results posted yet for this study

Summary

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.

Conditions

  • Hypotension During Dialysis
  • Fluid Overload

Interventions

DRUG

(100 ml of Albumin 25%)

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

Sponsors & Collaborators

Principal Investigators

  • Ravindra L Mehta, MD · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-03
Primary Completion
2017-12-15
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04522635 on ClinicalTrials.gov