Angiotensin II in Liver Transplantation (AngLT-1)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    50
  • sponsor
    University of California, San Francisco
Updated on 4 October 2022
angiotensin ii

Summary

The purpose of this study is to determine the efficacy and safety of Angiotensin II as a second-line vasopressor (drug that raises the blood pressure) during liver transplantation.

Description

This is a single center, randomized, double-blind, placebo-controlled trial. Subjects will receive an infusion of either Angiotensin II (AngII) or a saline control (placebo) in addition to usual care with traditional vasopressors (catecholamines and vasopressin) during liver transplantation (LT). AngII is a vasopressor approved by the FDA for the treatment of vasodilatory shock. It targets the renin-angiotensin system (RAS) and has been shown to effectively raise the mean arterial blood pressure (MAP) in patients with septic shock. It also allows for lower doses of traditional vasopressors and may improve microcirculatory flow to the kidneys. The study drug will only be administered if the participants require > 0.05 mcg/kg/min of norepinephrine while undergoing liver transplantation. The study drug will be titrated throughout the case and discontinued at the end of surgery. Randomization will be stratified based on (a) the need for renal replacement therapy preoperatively and (b) the use of normothermic machine perfusion of the liver graft.

Details
Condition Liver Transplant; Complications, Vasoplegia
Treatment Saline, Angiotensin II
Clinical Study IdentifierNCT04901169
SponsorUniversity of California, San Francisco
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age > or = 18 years
Liver transplantation from a deceased donor after brain death (DBD)
Model for End-stage Liver Disease Sodium (MELD-Na) score > or = 25 at the time of transplant (not counting MELD exception points)
Patient requiring > 0.05 mcg/kg/min of norepinephrine (NE) during LT

Exclusion Criteria

Living-donor liver transplantation (LDLT)
Split liver transplantation (isolated right or left lobe)
Donation after cardiac death (DCD)
Acute liver failure (ALF)
Listed for or receiving simultaneous liver-kidney transplantation (SLKT)
Liver re-transplantation (patient who has previously received a liver transplant)
Preoperative treatment with angiotensin II receptor blocker or angiotensin converting enzyme inhibitor (within 48 h)
Portopulmonary hypertension
Left ventricular systolic dysfunction (defined as ejection fraction < 45%)
Active bronchospasm at time of LT
History of thrombotic or embolic disease, inherited hypercoagulable disorder, or therapeutic anticoagulation
Portal vein thrombosis
Celiac stenosis
End-stage renal disease (chronic eGFR < 15 mL/min/1.73 m2 or chronic RRT - not including AKI requiring RRT)
History of Raynaud's disease
Known history of allergy to synthetic human angiotensin II
Subject intubated and/or mechanically ventilated prior to entering OR for LT
Presence of other condition or abnormality that would compromise the safety of the patient or quality of the data
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