Initial Resuscitation for Acute Kidney Injury in Cirrhosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06525623
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • Cirrhosis, Liver
  • Hepatorenal Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Recommendation: No Further Resuscitation — OTHER
    Treatment teams are encouraged not to administer any additional fluids
  • Recommendation: Resuscitation with Crystalloid — OTHER
    Treatment teams are encouraged to administer crystalloid. Amount of resuscitative fluid will be determined by treatment team's clinical assessments and usual standards of care
  • Recommendation: Resuscitation with Colloid — OTHER
    Treatment teams are encouraged to administer colloid. Amount of resuscitative fluid will be determined by treatment team's clinical assessments and usual standards of care
  • Recommendation: Standard of Care IV Albumin — OTHER
    Treatment teams are encouraged to administer 1 g/kg/d IV albumin (maximum 100 g/day) over 2 days

Study Details

The goal of this interventional study is to evaluate two strategies for how to provide intravenous (IV) fluids for treating patients with acute kidney injury (AKI) in cirrhosis. The main question it aims to answer is: what is the safety, efficacy, and feasibility of providing a recommendation to use a Volume Assessment Guidance Algorithm (VAGA) or give standard of care doses of IV albumin? Patients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation.

Key Dates

Start date
Sep 12, 2024
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VAGA Group
    This group will receive an algorithm-based recommendation based on the 2024 Acute Disease Quality Initiative (ADQI)/International Club of Ascites (ICA) joint consensus meeting on AKI in cirrhosis, which recommends a personalized approach to AKI in cirrhosis in order to avoid volume overload. This includes balanced crystalloids as first-line resuscitative fluids unless there is a patient-specific indication for an alternative colloid (e.g. blood for gastrointestinal bleeding, IV albumin for spontaneous bacterial peritonitis or suspicion of hepatorenal syndrome), or no further resuscitation.
  • Placebo Comparator: Standard of Care
    This group will receive a recommendation based on the 2021 American Association for the Study of Liver Diseases (AASLD) and 2018 European Association for the Study of the Liver (EASL) clinical practice guidelines, which recommends a 1 g/kg/d IV albumin (maximum 100 g/day) IV albumin over 2 days as an initial resuscitation approach for patients with AKI and cirrhosis.

Primary Outcome Measure

IV albumin received (grams) [ Time Frame: From date of randomization up to 48 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Sydney Whittaker, BS
[email protected]
6177263465
Andrew S Allegretti, MD, MSc
[email protected]
Andrew S Allegretti, MD Msc (PRINCIPAL_INVESTIGATOR)

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