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Fluid Resuscitation

VAGA Group for Liver Cirrhosis (RAKI-VAGA Trial)

N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization up to 90 days
Awards & highlights

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.

Who is the study for?
This trial is for patients with liver cirrhosis who have developed acute kidney injury. Participants should not be receiving any other treatments that could affect the study results, and they must be able to follow the trial procedures.
What is being tested?
The study compares two methods of giving IV fluids in cirrhosis patients with acute kidney injury: a Volume Assessment Guidance Algorithm (VAGA) recommendation versus standard care with IV albumin. Patients are randomly assigned to one of these approaches.
What are the potential side effects?
Potential side effects may include fluid overload, electrolyte imbalances, or reactions at the infusion site due to different types of IV fluids used during resuscitation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to suggested guidance
Incidence of treatment-emergent adverse events and serious adverse events
Secondary study objectives
AKI Response
IV albumin received (grams)
Liver transplant
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VAGA GroupExperimental Treatment3 Interventions
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: Standard of CarePlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,979 Previous Clinical Trials
13,220,250 Total Patients Enrolled
9 Trials studying Liver Cirrhosis
670 Patients Enrolled for Liver Cirrhosis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,395 Previous Clinical Trials
4,318,477 Total Patients Enrolled
25 Trials studying Liver Cirrhosis
7,393 Patients Enrolled for Liver Cirrhosis
~33 spots leftby Mar 2026
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