Evaluating fluid treatment strategies for kidney injury in cirrhosis patients

Initial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis: A Pilot Randomized Trial Using a Volume Assessment Guidance Algorithm

This study is testing two different ways to give IV fluids to people with kidney injury and cirrhosis to see which method helps them feel better and survive longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06525623 on ClinicalTrials.gov

What this trial studies

This interventional study aims to compare two strategies for administering intravenous fluids to patients with acute kidney injury (AKI) and cirrhosis. Participants will be randomly assigned to receive either a Volume Assessment Guidance Algorithm (VAGA) recommendation or standard care doses of IV albumin. The study will assess the safety, efficacy, and feasibility of these approaches, measuring outcomes such as albumin administration, AKI response rates, and survival. Follow-up assessments will occur at 48 hours, hospital discharge, and 90 days post-randomization.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with decompensated cirrhosis and acute kidney injury.

Not a fit: Patients requiring more than 2 liters of supplemental oxygen or those in shock needing vasopressors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment protocols for patients with acute kidney injury in the context of cirrhosis, potentially enhancing recovery and survival rates.

How similar studies have performed: While similar approaches have been explored, this specific comparison of VAGA versus standard IV albumin is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)

Conditions Cirrhosis, Liver; Acute Kidney Injury; Hepatorenal Syndrome