Status:
RECRUITING
Angiotensin II in Liver Transplantation
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
La Jolla Pharmaceutical Company
Conditions:
Liver Transplant; Complications
Vasoplegia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04901169
Start Date
June 28 2022
End Date
September 1 2026
Last Update
May 21 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143