Angiotensin 2 for AKI After OLT

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT04592744
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Acute Kidney Injury
  • Cirrhosis, Liver
  • End Stage Liver DIsease
  • Liver Transplant; Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Angiotensin II — DRUG
    Angiotensin II infusion for Intraoperative management during liver transplantation
  • Norepinephrine — DRUG
    Vasopressor infusion for management of Intraoperative hypotension in liver transplantation.

Study Details

Kidney injury is a common complication following liver transplantation and is associated with a higher complication rate and increased risk of death. While there are many factors that likely contribute to kidney injury in the perioperative period, a relative low serum level of angiotensin 2 (Ang 2) (a protein hormone that causes blood vessels to narrow) found in patients with liver cirrhosis (late stage of liver damage) may increase their risk of developing acute kidney injury (sudden episode of kidney failure or damage). We propose to investigate how early administration of Ang 2, a new vasopressor drug approved by the FDA in December 2017 for patients with low blood pressure, during the intra-operative period of liver transplant surgery affects the rate of kidney injury after transplantation. Patients who are deemed appropriate candidates for the study will be randomized 1:1 to the treatment and control groups. The intervention period of the study will occur in the operating room during transplant surgery and will be performed by their anesthesiologists. In the Treatment group, patients will receive Ang 2 infusions in addition to other standard vasopressors while patients in the control group will receive standard vasopressors alone. The infusion of Ang 2 in the treatment group will continue through the duration of the surgery and will be stopped prior to leaving the operating room. Both the treatment group and the control group will then be followed for 14 days to evaluate rates of kidney injury and to look for any complications. The follow up period will be extended to 28 days to look at in-hospital mortality rates in both groups. The daily follow up analysis will occur while the enrolled patients are inpatient following their transplantation surgery and will be done by looking at lab values and other data that is routinely gathered by their managing teams. This study will serve as a pilot study to evaluate feasibility of our protocol and to collect some preliminary data on the use of Ang 2 in this patient population. As such we plan to enroll approximately 30 patients who have accepted an offer to receive a donor liver. We hope to reach our goal enrollment within 5 months of starting the study.

Key Dates

Start date
Apr 8, 2022
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention
    Patients assigned to the study group will receive Ang 2 infusion in addition to standard vasopressor regimen. Ang 2 is currently approved at UCLA as a second line vasopressor and will be used as such for the purposes of our study. Hemodynamic goals will be established at the beginning of the case by the anesthesiology and surgical teams. Ang 2 will be started as a second vasopressor once the norepinephrine dose has reached 0.05mcg/kg/min. Ang 2 will be initiated at a starting dose of 5ng/kg/min. That dose will be up titrated one time to 10ng/kg/min as vasopressor requirements escalate. Once a patient is on the 10ng/kg/min dose of ang 2, no additional up titration will be performed. Hemodynamic management will continue throughout the case with titration of other vasopressors as needed. Ang 2 will be continued throughout the intraoperative period but will be weaned off prior to leaving the operating room.
  • Active Comparator: Control
    Patients assigned to the control group will undergo intraoperative management with a standard vasopressor regimen composed of norepinephrine, vasopressin and epinephrine based on hemodynamic goals established by the surgical and anesthesia teams prior to surgery.

Primary Outcome Measure

Incidence of Acute kidney Injury [ Time Frame: Every day for 14 days following intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative MedicineLos AngelesCalifornia90095-

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Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine· Los Angeles, CA

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