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New algorithm aims to guide fluid treatment for kidney injury in cirrhosis patients

NCT ID NCT06525623

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a volume assessment guidance algorithm (VAGA) to help doctors decide how much and what type of IV fluid to give cirrhosis patients with acute kidney injury. Fifty hospitalized adults with cirrhosis and kidney injury will be randomly assigned to receive either VAGA-guided recommendations or standard IV albumin. The goal is to see if the algorithm is safe, practical, and effective at guiding fluid therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IV fluids (crystalloid, colloid, or albumin) guided by a volume assessment algorithm
What this could lead to
If successful, this could provide a safer, more effective way to manage fluids for kidney injury in cirrhosis patients, potentially reducing complications.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply broadly. The algorithm may not improve outcomes over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. 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: 1. Requiring \>2 liters (L) supplemental oxygen at the time of screening. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

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