Initial Resuscitation for Acute Kidney Injury in Cirrhosis
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
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
Treatments tested in this trial
- Recommendation: No Further Resuscitation
- Recommendation: Resuscitation with Crystalloid
- Recommendation: Resuscitation with Colloid
- Recommendation: Standard of Care IV Albumin
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov