Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT06525623

Conditions

Cirrhosis, Liver

Acute Kidney Injury

Hepatorenal Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Recommendation: No Further Resuscitation

Recommendation: Resuscitation with Crystalloid

Recommendation: Resuscitation with Colloid

Recommendation: Standard of Care IV Albumin

Study Details

Brief 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.

Conditions

Cirrhosis, Liver

Acute Kidney Injury

Hepatorenal Syndrome

Study ID

NCT06525623

Start date

Sep 12, 2024

Status verified date

Mar, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult age 18 years or greater
2. 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.
3. Admitted to the hospital
4. Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission).
5. 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:

1. Requiring >2 liters (L) supplemental oxygen at the time of screening.
2. In shock requiring vasopressors (vasoconstrictors for the treatment of AKI such as terlipressin, midodrine, and octreotide are allowed).
3. Allergy or other contraindication to IV albumin administration.
4. Death, liver transplant, or renal replacement therapy (RRT) expected within 48 hours.
5. Patient and/or legally authorized representative unable to provide informed consent.
6. Hepatic encephalopathy grade 3 or 4 at the time of screening.
7. Already received >200 g albumin during admission at the time of screening.
8. Severe, active bleeding requiring 3 or more units of red blood cell transfusion in the 48 hours prior to screening.
9. Admission to the intensive care unit at the time of screening.
10. Mechanical ventilation at the time of screening.
11. Presence of New York Heart Association (NYHA) class 3-4 symptoms of congestive heart failure at the time of screening.
12. History of prior liver or kidney transplant.
13. Pregnant or nursing status
14. Any condition, in the opinion of the investigator, that could confound or interfere with the safe completion of study activities.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Recommendation: No Further Resuscitation

Treatment teams are encouraged not to administer any additional fluids

Recommendation: Resuscitation with Crystalloid

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

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

Treatment teams are encouraged to administer 1 g/kg/d IV albumin (maximum 100 g/day) over 2 days

Primary outcome measure

  • IV albumin received (grams) [ Time Frame: From date of randomization up to 48 hours ]
  • Adherence to suggested guidance [ Time Frame: From date of randomization up to 48 hours ]
  • Incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: From date of randomization up to hospital discharge, assessed up to 90 days ]

Central Contacts and Locations

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Andrew S Allegretti, MD, MSc

aallegretti@mgh.harvard.edu

Principal Investigator:

Andrew S Allegretti, MD Msc

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-13.