RecruitingNot Applicable

Initial Resuscitation for Acute Kidney Injury in Cirrhosis

United States50 participantsStarted 2024-09-12

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult age 18 years or greater
✓. Signed informed consent form (ICF) by any subject capable of giving consent, or, when the subject is not capable of giving consent, by their legally authorized representatives prior to initiation of any study procedures.
✓. Admitted to the hospital
✓. Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission).
✓. Presence of acute kidney injury (AKI) as defined by International Club of Ascites (ICA) criteria, defined as SCr increase of ≥0.3 mg/dL within 48 hours or ≥50% increase from baseline which is known or presumed to have occurred within the prior 7 days.

Exclusion criteria

✕. Requiring \>2 liters (L) supplemental oxygen at the time of screening.
✕. In shock requiring vasopressors (vasoconstrictors for the treatment of AKI such as terlipressin, midodrine, and octreotide are allowed).
✕. Allergy or other contraindication to IV albumin administration.

What they're measuring

IV albumin received (grams)

Timeframe: From date of randomization up to 48 hours

Adherence to suggested guidance

Timeframe: From date of randomization up to 48 hours

Incidence of treatment-emergent adverse events and serious adverse events

Timeframe: From date of randomization up to hospital discharge, assessed up to 90 days

Trial details

NCT IDNCT06525623

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-01

View on ClinicalTrials.gov More Cirrhosis, Liver trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult age 18 years or greater
✓. Signed informed consent form (ICF) by any subject capable of giving consent, or, when the subject is not capable of giving consent, by their legally authorized representatives prior to initiation of any study procedures.
✓. Admitted to the hospital
✓. Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission).
✓. Presence of acute kidney injury (AKI) as defined by International Club of Ascites (ICA) criteria, defined as SCr increase of ≥0.3 mg/dL within 48 hours or ≥50% increase from baseline which is known or presumed to have occurred within the prior 7 days.

Exclusion criteria

✕. Requiring \>2 liters (L) supplemental oxygen at the time of screening.
✕. In shock requiring vasopressors (vasoconstrictors for the treatment of AKI such as terlipressin, midodrine, and octreotide are allowed).
✕. Allergy or other contraindication to IV albumin administration.

What they're measuring

IV albumin received (grams)

Timeframe: From date of randomization up to 48 hours

Adherence to suggested guidance

Timeframe: From date of randomization up to 48 hours

Incidence of treatment-emergent adverse events and serious adverse events

Timeframe: From date of randomization up to hospital discharge, assessed up to 90 days