Initial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis: A Pilot Randomized Trial Using a Volume Assessment Guidance Algorithm
Massachusetts General Hospital
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.
Description
This randomized, open-label, pilot feasibility trial will assess a volume assessment guidance algorithm (VAGA) in patients with AKI and cirrhosis. Eligible patients must have AKI and decompensated cirrhosis. In addition to assessing the adherence to the suggested guidance, this study will measure the effect of the study intervention on grams of albumin given, clinical efficacy outcomes (AKI response rates, survival, RRT status, transplant status), and safety. Patients who meet eligibility criteria will be randomized 1:1 where the treating clinicians will receive a one-time recommendation for…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- OtherRecommendation: No Further Resuscitation
Treatment teams are encouraged not to administer any additional fluids
- OtherRecommendation: 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
- OtherRecommendation: 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
- OtherRecommendation: Standard of Care IV Albumin
Treatment teams are encouraged to administer 1 g/kg/d IV albumin (maximum 100 g/day) over 2 days
Location
- Massachusetts General HospitalBoston, Massachusetts