Clinical trial

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

Name

20-30948

Description

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.

Trial arms

Trial start

2022-06-28

Estimated PCD

2025-09-01

Trial end

2026-09-01

Status

Recruiting

Phase

Early phase I

Treatment

Angiotensin II

Infusion of Angiotensin II initiated if participants require norepinephrine at a rate of \> 0.05 mcg/kg/min. The infusion will be titrated no more frequently than every 10 minutes during liver transplantation as a second line vasopressor and discontinued prior to leaving the operating room when the surgery is complete.

Arms:

Angiotensin II (Giapreza)

Other names:

Giapreza (synthetic human angiotensin II)

Saline

Infusion of 0.9% saline initiated if participants require norepinephrine at a rate of \> 0.05 mcg/kg/min. The infusion will be titrated no more frequently than every 10 minutes during liver transplantation as a second line vasopressor and discontinued prior to leaving the operating room when the surgery is complete.

Arms:

Saline

Other names:

0.9% normal saline

Size

Primary endpoint

Total dose of norepinephrine (NE), averaged over case duration and total body weight, utilized during liver transplantation (LT) to maintain mean arterial pressure (MAP) greater than or equal to 65 mmHg.

Duration of surgery - defined as the time period starting with skin incision by the surgeon, and ending at the time of skin closure, an average of 8 hours.

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Identically-labeled infusion bags of either angiotensin II or saline placebo will be prepared by a research pharmacist.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-12-21

1 organization

2 products

2 indications

Organization

University of California, San Francisco

Product

Indication

Indication

Product