Summary

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

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 the need for renal replacement therapy preoperatively.

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 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

You CAN'T join if...

  • 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

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientists at UCSF

  • Erika L Brinson, M.D.
    Assistant Professor, Anesthesia.
  • Michael P Bokoch, M.D., Ph.D.
    Assistant Professor, Anesthesia. Authored (or co-authored) 23 research publications. Research interests: liver transplant anesthesia · vascular anesthesia · acute kidney injury · molecular pharmacology · endothelium · coagulation · beta blockers · pupillometry · G-protein-coupled receptors.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04901169
Phase
Phase 2/3
Study Type
Interventional
Last Updated