NCT06525623 · Massachusetts General Hospital
Initial Resuscitation for Acute Kidney Injury in Cirrhosis
(RAKI-VAGA)
What this study is about
The goal of this interventional study is to evaluate two strategies for how to provide given through a vein (IV) (IV) fluids for treating patients with acute kidney injury (AKI) in cirrhosis.
View original scientific description
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.
Interventions
OTHER
Recommendation: No Further Resuscitation
Treatment teams are encouraged not to administer any additional fluids
OTHER
Recommendation: 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
OTHER
Recommendation: 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
OTHER
Recommendation: Standard of Care IV Albumin
Treatment teams are encouraged to administer 1 g/kg/d IV albumin (maximum 100 g/day) over 2 days
Primary outcome measures
IV albumin received (grams)
Time frame: From date of randomization up to 48 hours
Adherence to suggested guidance
Time frame: From date of randomization up to 48 hours
For the VAGA group, adherence is defined as: No further resuscitation (\<500 mL total volume of IV fluid given), Resuscitation with crystalloid (\>500 mL total IV fluid given, with \<50 g IV albumin and ≤2 units blood), Resuscitation with colloid (≥50 g IV albumin or ≥2 units blood given). For the Standard of Care group, adherence is defined as receiving within 20% of the suggested IV albumin dose in grams.
Incidence of treatment-emergent adverse events and serious adverse events
Time frame: From date of randomization up to hospital discharge, assessed up to 90 days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Boston, Massachusetts
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations