Recruiting

RAKI-VAGAVolume Assessment Guidance Algorithm for Acute Kidney Injury in Cirrhosis

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What is being tested

Recommendation: No Further Resuscitation

+ Recommendation: Resuscitation with Crystalloid

+ Recommendation: Resuscitation with Colloid

Other
Who is being recruted

Urogenital Diseases+12

+ Digestive System Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: September 2024
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 12, 2024

Actual date on which the first participant was enrolled.

This study focuses on a new way to help patients with both acute kidney injury (AKI) and cirrhosis, a liver condition. The goal is to test a volume assessment guidance algorithm (VAGA) to see if it can improve how these patients are treated. People who have AKI and decompensated cirrhosis might face serious health issues, and finding better ways to manage their treatment could improve their survival and overall health. This research is important because it aims to offer a more tailored approach to fluid management, which is crucial for patients with these conditions. Participants in this study are randomly assigned to one of two groups. In one group, doctors receive guidance from the VAGA for deciding how much fluid to give, while the other group receives standard care with a specific amount of albumin, a type of protein, administered over two days. Researchers measure the amount of albumin given to patients, their response to the AKI treatment, and their overall health outcomes, such as the need for kidney replacement therapy or organ transplants. Follow-ups occur 48 hours after starting the treatment, at hospital discharge, and 90 days later to assess the effectiveness and safety of the treatment. The study aims to enroll around 50 adult patients at a single location.

Official TitleInitial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis: A Pilot Randomized Trial Using a Volume Assessment Guidance Algorithm
NCT06525623
Principal SponsorMassachusetts General Hospital
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesDigestive System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsFibrosisHepatorenal SyndromeKidney DiseasesLiver CirrhosisLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesAcute Kidney Injury

Criteria

5 inclusion criteria required to participate
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)
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14 exclusion criteria prevent from participating
Presence of New York Heart Association (NYHA) class 3-4 symptoms of congestive heart failure at the time of screening
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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.

Group II

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
Recruiting
One Study Center