RECRUITING

Angiotensin II in Liver Transplantation

Conditions

Liver Transplant; Complications Vasoplegia Angiotensin II Cirrhosis Liver Transplant Liver Transplantation Hypotension Acute Kidney Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-06-28

Study Completion:2026-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04901169

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Michael P Bokoch, M.D., Ph.D.

CONTACT

(415) 476-8389

michael.bokoch@ucsf.edu

Principal Investigator

Michael P Bokoch, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Perioperative Care, University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Michael P Bokoch, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Department of Anesthesia and Perioperative Care, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-28

Study Completion Date2026-09-01

Study Record Updates

Study Start Date2022-06-28

Study Completion Date2026-09-01

Terms related to this study

Keywords Provided by Researchers

Vasoplegia
Angiotensin II
Cirrhosis
Liver Transplant
Liver Transplantation
Hypotension
Acute Kidney Injury

Additional Relevant MeSH Terms

Liver Transplant; Complications
Vasoplegia