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Initial Resuscitation for Acute Kidney Injury in Cirrhosis

ConditionsCirrhosis, LiverAcute Kidney InjuryHepatorenal Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recommendation: No Further Resuscitation

    Other intervention

    Treatment teams are encouraged not to administer any additional fluids

  • Recommendation: Resuscitation with Crystalloid

    Other intervention

    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 Colloid

    Other intervention

    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 Albumin

    Other intervention

    Treatment teams are encouraged to administer 1 g/kg/d IV albumin (maximum 100 g/day) over 2 days

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: VAGA GroupExperimental treatment 3 interventions
Group B: Standard of CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

IV albumin received (grams)

Time frame
From date of randomization up to 48 hours
2

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.

Time frame
From date of randomization up to 48 hours
3

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

Secondary outcomes

1

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.
2

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).

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.
3

Vital Status

Alive or dead

Time frame
From date of randomization up to 90 days
4

Renal Replacement Therapy Initiation

Yes or No

Time frame
From date of randomization up to 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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