Initial Resuscitation for Acute Kidney Injury in Cirrhosis

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to give intravenous (IV) fluids to patients with acute kidney injury (AKI) who also have cirrhosis, which is a serious liver condition. The main goal is to find out which method is safer and more effective: using a special guideline called a Volume Assessment Guidance Algorithm (VAGA) or providing a standard dose of IV albumin, a type of protein solution. Patients will be randomly assigned to receive one of these two treatments, and researchers will closely monitor their health outcomes.

To participate in the trial, patients must be at least 18 years old, currently hospitalized, and have been diagnosed with advanced cirrhosis and AKI. However, there are some criteria that would exclude a patient from joining, such as being in shock, having severe breathing problems, or being unable to provide consent. Participants can expect to receive either the VAGA-guided treatment or standard IV albumin, and their progress will be closely observed to help determine which approach works better. This study aims to improve care for patients with these challenging conditions.

Gender

ALL

Eligibility criteria

• 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.