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Angiotensin 2 for AKI After OLT

StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary completion date: Dec 2025 to Dec 2026
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Study completion date: Mar 2026 to Dec 2026
    v6
  2. Notable Primary completion date: Sep 2024 to Dec 2025
    • Study completion date: Dec 2024 to Mar 2026
    • Study site revised
    v5
  3. Notable Primary completion date: Sep 2023 to Sep 2024
    • Study completion date: Dec 2023 to Dec 2024
    v4
  4. Notable Primary completion date: Sep 2022 to Sep 2023
    • Study completion date: Dec 2022 to Dec 2023
    v3
  5. Notable Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 4 more changesShow less
    • Primary completion date: Apr 2021 to Sep 2022
    • Start date changed from estimate of Nov 2020 to Apr 8, 2022
    • Study sites: 0 to 1
    • Study completion date: Jun 2021 to Dec 2022
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04592744
Lead Sponsor University of California, Los Angeles
Conditions
(from sponsor)
Cirrhosis, Liver, End Stage Liver DIsease, Acute Kidney Injury, Liver Transplant; Complications
Related terms Acute Kidney Injury, End Stage Liver Disease, Liver Cirrhosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov