Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury

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.

Study Overview

• Status: Completed
• Conditions: Fluid Overload; Hypotension During Dialysis
• Intervention / Treatment: Drug: (100 ml of Albumin 25%)

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

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• allergy to the components of albumin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: albumin; albumin (100 ml of Grifols 25%) given intravenously at the start of IHD	Drug: (100 ml of Albumin 25%); single dose of 25g albumin (100 ml of Grifols 25%) given intravenously at the start of IHD; Other Names: albumin
PLACEBO_COMPARATOR: normal saline; 0.9% sodium chloride (normal saline (NS)) given intravenously at the start of IHD	Drug: (100 ml of Albumin 25%); single dose of 25g albumin (100 ml of Grifols 25%) given intravenously at the start of IHD; Other Names: albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fluid removal	achieved fluid removal expressed as ml/kg/hour	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypotension	cardiovascular complications, including hypotensive episodes	during procedure

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Grifols Biologicals, LLC
• Investigators: Principal Investigator: Ravindra L Mehta, MD, UCSD

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2015
• Primary Completion (ACTUAL): December 15, 2017
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (ACTUAL): August 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Hypotension
• Other Study ID Numbers: 141779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No