Initial Resuscitation for Acute Kidney Injury in Cirrhosis

This study is for adults hospitalized with cirrhosis (severe liver scarring) and acute kidney injury (AKI), a sudden decrease in kidney function. It aims to find the best way to give intravenous (IV) fluids to these patients. Researchers are comparing different approaches: encouraging no further fluids, giving crystalloid fluids, giving colloid fluids, or giving standard doses of IV albumin (a protein found in blood). You would be randomly assigned to a group where your medical team receives a recommendation for one of these approaches. The study will look at how much IV albumin is given, how well the medical teams follow the recommendations, and any side effects. This will help doctors understand which fluid strategy is safest and most effective.

Study design
This is a randomized, open-label pilot study planning to enroll 50 participants. Participants will be randomly assigned to a group where their medical team receives a specific recommendation for IV fluid treatment.
What's involved
You would be assessed at 48 hours after randomization, at hospital discharge, and 90 days after randomization.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up to 90 days after randomization, or until hospital discharge, liver transplant, or initiation of RRT (renal replacement therapy, like dialysis).

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NCT06525623

Initial Resuscitation for Acute Kidney Injury in Cirrhosis

Recruiting
NAAges 18+InterventionalTreatment
Massachusetts General Hospital
~50 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Recommendation: No Further ResuscitationRecommendation: Resuscitation with CrystalloidRecommendation: Resuscitation with ColloidRecommendation: Standard of Care IV Albumin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
IV albumin received (grams)
Measured over From date of randomization up to 48 hours
+2 more outcomes measured
Cirrhosis, Liver
Acute Kidney Injury
Hepatorenal Syndrome
1 sites across 1 states
Massachusetts1

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  • IV albumin received (grams)From date of randomization up to 48 hours
  • Adherence to suggested guidanceFrom date of randomization up to 48 hours

    For the VAGA group, adherence is defined as: No further resuscitation (\<500 mL total volume of IV fluid given), Resuscitation with crystalloid (\>500 mL total IV fluid given, with \<50 g IV albumin and ≤2 units blood), Resuscitation with colloid (≥50 g IV albumin or ≥2 units blood given). For the Standard of Care group, adherence is defined as receiving within 20% of the suggested IV albumin dose in grams.

  • Incidence of treatment-emergent adverse events and serious adverse eventsFrom date of randomization up to hospital discharge, assessed up to 90 days