Angiotensin II in Liver Transplantation

a study on Liver Transplant Vasoplegia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Michael P Bokoch, M.D., Ph.D.

Description

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.

Official Title

Angiotensin II in Liver Transplantation (AngLT-1): A Pilot Randomized Controlled Trial

Details

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.

Keywords

Liver Transplant; Complications, Vasoplegia, Angiotensin II, Cirrhosis, Liver Transplant, Liver Transplantation, Hypotension, Acute Kidney Injury, Giapreza, Angiotensinogen, Saline, Angiotensin II (Giapreza)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age > or = 18 years
  • Liver transplantation from a deceased donor
  • 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

You CAN'T join if...

  • Living-donor liver transplantation (LDLT)
  • Split liver transplantation (isolated right or left lobe)
  • Donation after cardiac death (DCD) without normothermic machine perfusion (NMP)
  • 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

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04901169
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated
Contact us about this trial