Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury
Primary Purpose
Hypotension During Dialysis, Fluid Overload
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
(100 ml of Albumin 25%)
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension During Dialysis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
albumin
normal saline
Arm Description
albumin (100 ml of Grifols 25%) given intravenously at the start of IHD
0.9% sodium chloride (normal saline (NS)) given intravenously at the start of IHD
Outcomes
Primary Outcome Measures
fluid removal
achieved fluid removal expressed as ml/kg/hour
Secondary Outcome Measures
hypotension
cardiovascular complications, including hypotensive episodes
Full Information
NCT ID
NCT04522635
First Posted
August 18, 2020
Last Updated
August 20, 2020
Sponsor
University of California, San Diego
Collaborators
Grifols Biologicals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04522635
Brief Title
Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury
Official Title
Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 3, 2015 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Grifols Biologicals, LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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:
Addition of albumin solutions to dialysis therapy will enhance the efficacy of fluid removal (total amount of fluid removed)
Albumin solutions will improve the efficiency of fluid removal by dialysis per unit time
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:
Addition of albumin solutions will reduce the frequency of Intradialytic hypotension associated with fluid removal on dialysis.
Albumin solutions given during dialysis will reduce the incidence and magnitude of myocardial stunning associated with fluid removal on dialysis
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:
Patients with AKI or ESRD will have deranged microcirculatory profile as compared to normal
During fluid removal with dialysis changes in microcirculation correlate with alterations in hemodynamics related to the rate and amount of fluid removal
Utilization of IV albumin during dialysis will reduce the microcirculatory stress of fluid removal
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension During Dialysis, Fluid Overload
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Patients will be randomized for a minimum of 4 and maximum of 6 consecutive dialysis sessions to one of two sequences:
Sequence A: Albumin in sessions 1, 3 and 5 and saline in sessions 2, 4 and 6
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
albumin
Arm Type
Active Comparator
Arm Description
albumin (100 ml of Grifols 25%) given intravenously at the start of IHD
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride (normal saline (NS)) given intravenously at the start of IHD
Intervention Type
Drug
Intervention Name(s)
(100 ml of Albumin 25%)
Other Intervention Name(s)
albumin
Intervention Description
single dose of 25g albumin (100 ml of Grifols 25%) given intravenously at the start of IHD
Primary Outcome Measure Information:
Title
fluid removal
Description
achieved fluid removal expressed as ml/kg/hour
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
hypotension
Description
cardiovascular complications, including hypotensive episodes
Time Frame
during procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravindra L Mehta, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33407747
Citation
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.
Results Reference
derived
Learn more about this trial
Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury
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