Cirrhosis, LiverRAKI-VAGANCT06525623

Initial Resuscitation for Acute Kidney Injury in Cirrhosis

A study testing Recommendation: No Further Resuscitation, Recommendation: Resuscitation with Crystalloid and Recommendation: Resuscitation with Colloid in people with Cirrhosis, Liver and Acute Kidney Injury, run by Massachusetts General Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cirrhosis, Liver, Acute Kidney Injury, Hepatorenal Syndrome
What is being tested?: Recommendation: No Further Resuscitation, Recommendation: Resuscitation with Crystalloid and Recommendation: Resuscitation with Colloid
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 12 Sep 2024to 1 May 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).
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.

Who cannot join

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.
Death, liver transplant, or renal replacement therapy (RRT) expected within 48 hours.
Patient and/or legally authorized representative unable to provide informed consent.
Hepatic encephalopathy grade 3 or 4 at the time of screening.

Show all 14Show fewer

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.
Admission to the intensive care unit at the time of screening.
Mechanical ventilation at the time of screening.
Presence of New York Heart Association (NYHA) class 3-4 symptoms of congestive heart failure at the time of screening.
History of prior liver or kidney transplant.
Pregnant or nursing status
Any condition, in the opinion of the investigator, that could confound or interfere with the safe completion of study activities.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

Massachusetts General Hospital
Boston, Massachusetts, 02114
Sydney Whittaker, BS, 6177263465, swhittaker3@mgh.harvard.edu
Andrew S Allegretti, MD, MSc, aallegretti@mgh.harvard.edu
Recruiting

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About this study

Official title: Initial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis: A Pilot Randomized Trial Using a Volume Assessment Guidance Algorithm

Patients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation.

Read the detailed description

This randomized, open-label, pilot feasibility trial will assess a volume assessment guidance algorithm (VAGA) in patients with AKI and cirrhosis. Eligible patients must have AKI and decompensated cirrhosis. In addition to assessing the adherence to the suggested guidance, this study will measure the effect of the study intervention on grams of albumin given, clinical efficacy outcomes (AKI response rates, survival, RRT status, transplant status), and safety.

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: Cirrhosis, Liver, Acute Kidney Injury, Hepatorenal Syndrome
Being tested: Recommendation: No Further Resuscitation, Recommendation: Resuscitation with Crystalloid, Recommendation: Resuscitation with Colloid, Recommendation: Standard of Care IV Albumin
Medical subject headings: Liver Cirrhosis, Acute Kidney Injury, Hepatorenal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recommendation: No Further ResuscitationOther
Treatment teams are encouraged not to administer any additional fluids
Recommendation: Resuscitation with CrystalloidOther
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 ColloidOther
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 AlbuminOther
Treatment teams are encouraged to administer 1 g/kg/d IV albumin (maximum 100 g/day) over 2 days

Study groups in NCT06525623
Study group	Role	What they receive
VAGA Group	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. Receives: Other: Recommendation: No Further Resuscitation; Other: Recommendation: Resuscitation with Crystalloid; Other: Recommendation: Resuscitation with Colloid
Standard of Care	Placebo comparator	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. Receives: Other: Recommendation: Standard of Care IV Albumin

What is being measured

The primary outcome is the main question the study is designed to answer.

IV albumin received (grams)
Measured: From date of randomization up to 48 hours
Adherence to suggested guidance
For the VAGA group, adherence is defined as: No further resuscitation (<500 mL total volume of IV fluid given), Resuscitation with crystalloid (>500 mL total IV fluid given, with <50 g IV albumin and ≤2 units blood), Resuscitation with colloid (≥50 g IV albumin or ≥2 units blood given). For the Standard of Care group, adherence is defined as receiving within 20% of the suggested IV albumin dose in grams.
Measured: From date of randomization up to 48 hours
Incidence of treatment-emergent adverse events and serious adverse events
Measured: From date of randomization up to hospital discharge, assessed up to 90 days

Secondary outcomes (5)

IV albumin received (grams)
Measured: From date of hospital admission up to hospital discharge, or the date of time of initiation of renal replacement therapy or liver transplant, whichever came first, assessed up to 90 days.
AKI Response
AKI response is defined as complete response (return of serum creatinine to a value within 0.3 mg/dL of the baseline value), partial response (regression of AKI stage with a reduction of serum creatinine (SCr) to ≥0.3 mg/dl above the baseline value), or no response (neither complete or partial response met).
Measured: From date of randomization up to hospital discharge, or the date of time of initiation of renal replacement therapy or liver transplant, whichever came first, assessed up to 90 days.
Vital Status
Alive or dead
Measured: From date of randomization up to 90 days
Renal Replacement Therapy Initiation
Yes or No
Measured: From date of randomization up to 90 days
Liver transplant
Yes or No
Measured: From date of randomization up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 20241 May 2027

First posted29 Jul 2024
Study start12 Sep 2024
Primary completion1 Mar 2027 (estimated)
Study completion1 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06525623
Sponsor's protocol ID: 2024P001520
Other IDs: K23DK128567
Acronym: RAKI-VAGA
Status last verified: Mar 2026
First submitted: 16 Jul 2024
Last updated: 13 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Intellectual property and data generated under this project will be administered in accordance with both Massachusetts General Hospital and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.

Publications

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.
PubMed 29653741
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.
PubMed 33942342
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.
PubMed 38527522

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Initial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis: A Pilot Randomized Trial Using a Volume Assessment Guidance Algorithm
ClinicalTrials.gov ID: NCT06525623
Acronym / sponsor ID: RAKI-VAGA / 2024P001520
Conditions: Cirrhosis, Liver, Acute Kidney Injury, Hepatorenal Syndrome
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 12 Sep 2024 (actual)
Primary completion: 1 Mar 2027 (estimated)
Study completion: 1 May 2027 (estimated)
First posted: 29 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

This study will prospectively enroll approximately 50 adult patients at a single center.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
VAGA Group	Experimental	Other: Recommendation: No Further Resuscitation, Other: Recommendation: Resuscitation with Crystalloid, Other: Recommendation: Resuscitation with ColloidThis 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.
Standard of Care	Placebo comparator	Other: Recommendation: Standard of Care IV AlbuminThis 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).
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.

Key exclusion criteria (14 listed)

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.
Death, liver transplant, or renal replacement therapy (RRT) expected within 48 hours.
Patient and/or legally authorized representative unable to provide informed consent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recommendation: No Further ResuscitationTreatment teams are encouraged not to administer any additional fluids	Other	VAGA Group
Recommendation: Resuscitation with CrystalloidTreatment teams are encouraged to administer crystalloid. Amount of resuscitative fluid will be determined by treatment team's clinical assessments and usual standards of care	Other	VAGA Group
Recommendation: Resuscitation with ColloidTreatment teams are encouraged to administer colloid. Amount of resuscitative fluid will be determined by treatment team's clinical assessments and usual standards of care	Other	VAGA Group
Recommendation: Standard of Care IV AlbuminTreatment teams are encouraged to administer 1 g/kg/d IV albumin (maximum 100 g/day) over 2 days	Other	Standard of Care

Primary outcome

IV albumin received (grams)
Time frame: From date of randomization up to 48 hours
Adherence to suggested guidance
Time frame: From date of randomization up to 48 hours
For the VAGA group, adherence is defined as: No further resuscitation (<500 mL total volume of IV fluid given), Resuscitation with crystalloid (>500 mL total IV fluid given, with <50 g IV albumin and ≤2 units blood), Resuscitation with colloid (≥50 g IV albumin or ≥2 units blood given). For the Standard of Care group, adherence is defined as receiving within 20% of the suggested IV albumin dose in grams.
Incidence of treatment-emergent adverse events and serious adverse events
Time frame: From date of randomization up to hospital discharge, assessed up to 90 days

5 secondary outcomes

IV albumin received (grams)
Time frame: From date of hospital admission up to hospital discharge, or the date of time of initiation of renal replacement therapy or liver transplant, whichever came first, assessed up to 90 days.
AKI Response
Time frame: From date of randomization up to hospital discharge, or the date of time of initiation of renal replacement therapy or liver transplant, whichever came first, assessed up to 90 days.
Vital Status
Time frame: From date of randomization up to 90 days
Renal Replacement Therapy Initiation
Time frame: From date of randomization up to 90 days
Liver transplant
Time frame: From date of randomization up to 90 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
Background: PubMed 29653741European 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.
Background: PubMed 33942342Biggins 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.
Background: PubMed 38527522Nadim 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.
Individual participant dataSharing planned: Yes. Intellectual property and data generated under this project will be administered in accordance with both Massachusetts General Hospital and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Massachusetts General Hospital

Boston, United States

6177263465

swhittaker3@mgh.harvard.edu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IV albumin received (grams) (time frame: From date of randomization up to 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06525623, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.