NCT06525623 Initial Resuscitation for Acute Kidney Injury in Cirrhosis

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 50 participants in total. It began in 2024-09-12 with a primary completion date of 2027-03-01.

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.

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.

Frequently Asked Questions

Related Trials