Initial Resuscitation for Acute Kidney Injury in Cirrhosis
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT06525623 · last updated 2026-03-13