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