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Fluid Resuscitation

Resuscitation Methods for Acute Kidney Injury in Liver Cirrhosis (RAKI-VAGA Trial)

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission)

Adult age 18 years or greater

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization up to 90 days

Summary

This trial aims to compare two methods of providing intravenous fluids to treat acute kidney injury in patients with cirrhosis. One group will receive a Volume Assessment Guidance Algorithm recommendation while the other will receive the

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

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I have been diagnosed with advanced liver disease.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received more than 200 grams of albumin during my current hospital stay.

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I needed 3 or more blood transfusions due to severe bleeding in the last 2 days.

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I am on a ventilator.

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I experience severe symptoms of heart failure.

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I have had a liver or kidney transplant in the past.

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I cannot give consent for medical procedures myself.

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I am not expected to undergo liver transplant, RRT, or face death within 48 hours.

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I need more than 2 liters of extra oxygen.

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I do not have severe confusion due to liver problems.

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I am currently in the intensive care unit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization up to 90 days

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

Secondary study objectives

AKI Response

Liver transplant

Renal Replacement Therapy Initiation

+1 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.

0 / 12Eligibility criteria met