Initial Resuscitation for Acute Kidney Injury in Cirrhosis
Recruiting now · Not applicable
Conditions studied: Cirrhosis, Liver, Acute Kidney Injury, Hepatorenal Syndrome
In brief
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.
Key facts
- Study ID
- NCT06525623
- Run by
- Massachusetts General Hospital
- People needed
- 50
- Starts
- 2024-09-12
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult age 18 years or greater
- 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.
- Admitted to the hospital
- Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission).
- 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…
- Requiring >2 liters (L) supplemental oxygen at the time of screening.
- In shock requiring vasopressors (vasoconstrictors for the treatment of AKI such as terlipressin, midodrine, and octreotide are allowed).
- Allergy or other contraindication to IV albumin administration.
- Death, liver transplant, or renal replacement therapy (RRT) expected within 48 hours.
- Patient and/or legally authorized representative unable to provide informed consent.
- Hepatic encephalopathy grade 3 or 4 at the time of screening.
- Already received >200 g albumin during admission at the time of screening.
- Severe, active bleeding requiring 3 or more units of red blood cell transfusion in the 48 hours prior to screening.
- Admission to the intensive care unit at the time of screening.
- Mechanical ventilation at the time of screening.
- Presence of New York Heart Association (NYHA) class 3-4 symptoms of congestive heart failure at the time of screening.
- History of prior liver or kidney transplant.
- Pregnant or nursing status
- Any condition, in the opinion of the investigator, that could confound or interfere with the safe completion of study activities.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.