Initial Resuscitation for Acute Kidney Injury in Cirrhosis
NCT ID: NCT06525623
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-09-12
2026-09-30
Brief Summary
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Patients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation.
Detailed Description
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Patients who meet eligibility criteria will be randomized 1:1 where the treating clinicians will receive a one-time recommendation for volume resuscitation using the VAGA or standard of care IV albumin repletion (1 g/kg/day for two days). Both groups will be followed with assessments at 48 hours after randomization, hospital discharge, and 90-days after randomization.
The primary efficacy outcome, grams of albumin, will be measured at 48 hours after randomization. Primary secondary efficacy outcomes (grams of albumin, AKI response) will be assessed at time of hospital discharge. If a patient undergoes liver transplantation or initiation of RRT during the admission, this will serve as a censoring date for these outcomes, and relevant data will be collected at the time of the first of these events.
The primary feasibility outcome is adherence to the suggested guidance, assessed at 48 hours after randomization. The VAGA group will receive one of three potential clinical recommendations: (a) no further volume resuscitation, (b) resuscitation with crystalloid, or (c) resuscitation with colloid.
This study will prospectively enroll approximately 50 adult patients at a single center.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VAGA Group
This group will receive an algorithm-based recommendation based on the 2024 Acute Disease Quality Initiative (ADQI)/International Club of Ascites (ICA) joint consensus meeting on AKI in cirrhosis, which recommends a personalized approach to AKI in cirrhosis in order to avoid volume overload. This includes balanced crystalloids as first-line resuscitative fluids unless there is a patient-specific indication for an alternative colloid (e.g. blood for gastrointestinal bleeding, IV albumin for spontaneous bacterial peritonitis or suspicion of hepatorenal syndrome), or no further resuscitation.
Recommendation: No Further Resuscitation
Treatment teams are encouraged not to administer any additional fluids
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
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
Standard of Care
This group will receive a recommendation based on the 2021 American Association for the Study of Liver Diseases (AASLD) and 2018 European Association for the Study of the Liver (EASL) clinical practice guidelines, which recommends a 1 g/kg/d IV albumin (maximum 100 g/day) IV albumin over 2 days as an initial resuscitation approach for patients with AKI and cirrhosis.
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
Interventions
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Recommendation: No Further Resuscitation
Treatment teams are encouraged not to administer any additional fluids
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
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
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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Andrew S. Allegretti, MD, MSC
Director of Critical Care Nephrology
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Facility Contacts
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Sydney Whittaker, BS
Role: primary
Andrew S Allegretti, MD, MSc
Role: backup
References
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European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available.
Biggins SW, Angeli P, Garcia-Tsao G, Gines P, Ling SC, Nadim MK, Wong F, Kim WR. 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. Hepatology. 2021 Aug;74(2):1014-1048. doi: 10.1002/hep.31884. No abstract available.
Nadim MK, Kellum JA, Forni L, Francoz C, Asrani SK, Ostermann M, Allegretti AS, Neyra JA, Olson JC, Piano S, VanWagner LB, Verna EC, Akcan-Arikan A, Angeli P, Belcher JM, Biggins SW, Deep A, Garcia-Tsao G, Genyk YS, Gines P, Kamath PS, Kane-Gill SL, Kaushik M, Lumlertgul N, Macedo E, Maiwall R, Marciano S, Pichler RH, Ronco C, Tandon P, Velez JQ, Mehta RL, Durand F. Acute kidney injury in patients with cirrhosis: Acute Disease Quality Initiative (ADQI) and International Club of Ascites (ICA) joint multidisciplinary consensus meeting. J Hepatol. 2024 Jul;81(1):163-183. doi: 10.1016/j.jhep.2024.03.031. Epub 2024 Mar 26.
Other Identifiers
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2024P001520
Identifier Type: -
Identifier Source: org_study_id