Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury

NCT ID: NCT04522635

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-03
• Study Completion Date: 2019-12-31

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.

Detailed Description

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?

The hypothesis to be tested:

1. Addition of albumin solutions will reduce the frequency of Intradialytic hypotension associated with fluid removal on dialysis.

2. Albumin solutions given during dialysis will reduce the incidence and magnitude of myocardial stunning associated with fluid removal on dialysis

3. Albumin solutions given during dialysis will reduce post-dialysis symptoms AIM 3: Does utilization of IV albumin improve the microcirculation in hospitalized patients undergoing fluid removal with dialysis?

The hypothesis to be tested:

1. Patients with AKI or ESRD will have deranged microcirculatory profile as compared to normal

2. During fluid removal with dialysis changes in microcirculation correlate with alterations in hemodynamics related to the rate and amount of fluid removal

3. Utilization of IV albumin during dialysis will reduce the microcirculatory stress of fluid removal

Conditions

Hypotension During Dialysis; Fluid Overload

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

albumin

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

Group Type: ACTIVE_COMPARATOR

(100 ml of Albumin 25%)

Intervention Type: DRUG

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

normal saline

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

Group Type: PLACEBO_COMPARATOR

(100 ml of Albumin 25%)

Intervention Type: DRUG

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

Interventions

(100 ml of Albumin 25%)

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

Intervention Type: DRUG

Other Intervention Names

albumin

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• allergy to the components of albumin

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Biologicals, LLC

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Ravindra Mehta

Professor Emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ravindra L Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

References

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.

Reference Type: DERIVED

PMID: 33407747 (View on PubMed)

Other Identifiers

141779

Identifier Type: -

Identifier Source: org_study_id