Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06525623

Initial Resuscitation for Acute Kidney Injury in Cirrhosis

Led by Massachusetts General Hospital · Updated on 2026-03-13

50

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Initial Resuscitation for Acute Kidney Injury in Cirrhosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult age 18 years or greater
  • Signed informed consent form by the participant or legally authorized representative
  • Currently admitted to the hospital
  • Diagnosis of decompensated cirrhosis before or at admission
  • Presence of acute kidney injury defined by specific criteria within the prior 7 days
Not Eligible

You will not qualify if you...

  • Requiring more than 2 liters of supplemental oxygen at screening
  • In shock needing vasopressors (except certain vasoconstrictors allowed)
  • Allergy or contraindication to IV albumin
  • Expected death, liver transplant, or renal replacement therapy within 48 hours
  • Unable to provide informed consent
  • Hepatic encephalopathy grade 3 or 4 at screening
  • Already received more than 200 grams of albumin during current admission
  • Severe active bleeding requiring 3 or more blood transfusions in prior 48 hours
  • Admitted to intensive care unit at screening
  • On mechanical ventilation at screening
  • New York Heart Association class 3 or 4 congestive heart failure symptoms
  • History of prior liver or kidney transplant
  • Pregnant or nursing
  • Any condition that could interfere with safe completion of the study as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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