search
Back to results

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
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension During Dialysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 18, 2020
    Last Updated
    August 20, 2020
    Sponsor
    University of California, San Diego
    Collaborators
    Grifols Biologicals, LLC
    search

    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

    We'll reach out to this number within 24 hrs