Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury

NCT04522635 | Completed Phase 4

• 1 other identifier: 141779
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• fluid removal

  achieved fluid removal expressed as ml/kg/hour

  during procedure

Secondary Outcomes (1)

• hypotension

  during procedure

Study Arms (2)

albumin

ACTIVE COMPARATOR

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

Drug: (100 ml of Albumin 25%)

normal saline

PLACEBO COMPARATOR

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

Drug: (100 ml of Albumin 25%)

Interventions

(100 ml of Albumin 25%) DRUG

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

Also known as: albumin

albumin; normal saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• allergy to the components of albumin

Sponsors & Collaborators

• University of California, San Diego: lead
• Grifols Biologicals, LLC: collaborator

Related Publications (1)

• Macedo E, Karl B, Lee E, Mehta RL. A randomized trial of albumin infusion to prevent intradialytic hypotension in hospitalized hypoalbuminemic patients. Crit Care. 2021 Jan 6;25(1):18. doi: 10.1186/s13054-020-03441-0.

  PMID: 33407747 DERIVED

MeSH Terms

Conditions

Edema

Interventions

Albumins

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Ravindra L Mehta, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Model Details: Patients will be randomized for a minimum of 4 and maximum of 6 consecutive dialysis sessions to one of two sequences: 1. Sequence A: Albumin in sessions 1, 3 and 5 and saline in sessions 2, 4 and 6 2. Sequence B: Saline in sessions 1, 3, 5 and albumin in sessions 2, 4 and 6 Dialysis Procedures (Standard of Care with the exception of Albumin which is additional and for research purposes only): All dialysis sessions will include standard procedures and monitoring. Dialysis prescriptions will be individualized for each patient and will be maintained through each of the 6 sessions.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: June 3, 2015
• Primary Completion: December 15, 2017
• Study Completion: December 31, 2019
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share