Overview

Angiotensin II in Liver Transplantation

Status:
Not yet recruiting
Trial end date:
2024-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
La Jolla Pharmaceutical Company
Treatments:
Angiotensin II
Angiotensinogen
Giapreza
Criteria
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