EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis.
European Association for the Study of the Liver
https://pubmed.ncbi.nlm.nih.gov/29653741Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06525623
Initial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis Using a Volume Assessment Guidance Algorithm: A Pilot Randomized Trial
Led by Massachusetts General Hospital · Updated on 2026-03-13
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two approaches for giving intravenous (IV) fluids to patients with acute kidney injury (AKI) in cirrhosis. This pilot randomized trial compares a Volume Assessment Guidance Algorithm (VAGA) recommendation versus standard doses of IV albumin to study safety, effectiveness, and feasibility. The study focuses on patients with AKI and decompensated cirrhosis and measures outcomes like albumin amount used, kidney injury response, survival, and use of renal replacement therapy or liver transplant. Participants will be randomly assigned to receive either a one-time VAGA-based recommendation or standard care IV albumin at 1 gram per kilogram per day for two days, up to 100 grams per day. The VAGA group may be advised to stop fluid resuscitation, use crystalloid fluids, or use colloid fluids based on clinical guidelines. Both groups will be monitored at 48 hours after randomization, at hospital discharge, and 90 days post-randomization to assess albumin usage, adherence to guidance, and clinical outcomes. Participants will be evaluated through clinical assessments and data collection during hospital stay and follow-up visits. Researchers will track the amount of IV albumin given, adherence to the assigned treatment recommendations, kidney injury response, vital status, and events like renal replacement therapy or liver transplant up to 90 days. Safety outcomes including adverse events will be reviewed up to hospital discharge and 90 days. The total study duration for each participant includes hospitalization and a 90-day follow-up period.
CONDITIONS
Brief Title
Initial Resuscitation for Acute Kidney Injury in Cirrhosis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult age 18 years or greater
- Signed informed consent form by the participant or legally authorized representative
- Admitted to the hospital
- Diagnosis of decompensated cirrhosis before or at admission
- Presence of acute kidney injury as defined by International Club of Ascites criteria within the prior 7 days
You will not qualify if you...
- Requiring more than 2 liters supplemental oxygen at screening
- In shock requiring vasopressors (except allowed vasoconstrictors for AKI treatment)
- Allergy or contraindication to IV albumin
- Expected death, liver transplant, or renal replacement therapy within 48 hours
- Unable to provide informed consent
- Hepatic encephalopathy grade 3 or 4 at screening
- Received more than 200 grams albumin during current admission
- Severe active bleeding needing 3 or more units of red blood cells in prior 48 hours
- Admission to intensive care unit at screening
- Mechanical ventilation at screening
- New York Heart Association class 3 or 4 congestive heart failure symptoms
- History of prior liver or kidney transplant
- Pregnant or nursing
- Any condition interfering with safe completion of study activities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 48 hours
Participants receive initial resuscitation treatment based on a volume assessment guidance algorithm or standard of care IV albumin repletion.
1 baseline visit and 1 follow-up visit at 48 hours
Hospital Discharge Assessment
Duration - Up to hospital discharge or event
Participants are assessed for treatment efficacy and safety at the time of hospital discharge or at initiation of renal replacement therapy or liver transplant.
1 visit (in-person) at hospital discharge or event
Follow-up
Duration - Up to 90 days after randomization
Participants are followed for clinical outcomes including survival, renal replacement therapy initiation, and liver transplant status up to 90 days after randomization.
Assessments at 90 days after randomization
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Diagnosis, Evaluation, and Management of Ascites, Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome: 2021 Practice Guidance by the American Association for the Study of Liver Diseases.
Scott W Biggins, Paulo Angeli, Guadalupe Garcia-Tsao...
https://pubmed.ncbi.nlm.nih.gov/33942342Acute kidney injury in patients with cirrhosis: Acute Disease Quality Initiative (ADQI) and International Club of Ascites (ICA) joint multidisciplinary consensus meeting.
Mitra K Nadim, John A Kellum, Lui Forni...
https://pubmed.ncbi.nlm.nih.gov/38527522