Using Angiotensin II to improve blood pressure during liver transplantation
Angiotensin II in Liver Transplantation (AngLT-1): A Pilot Randomized Controlled Trial
This study is testing if Angiotensin II can help improve blood pressure during liver transplant surgery for patients who need extra support.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04901169 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of Angiotensin II as a second-line vasopressor during liver transplantation. It is a single-center, randomized, double-blind, placebo-controlled trial where participants will receive either Angiotensin II or a saline placebo in addition to standard care with traditional vasopressors. The study focuses on patients requiring higher doses of norepinephrine during surgery, with the goal of improving blood pressure and potentially enhancing kidney microcirculation. The drug will be administered and adjusted throughout the procedure, with monitoring for safety and effectiveness.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old undergoing liver transplantation from deceased donors with a MELD-Na score of 25 or higher who require norepinephrine during the procedure.
Not a fit: Patients who may not benefit include those undergoing living-donor liver transplantation or those with acute liver failure or significant cardiac dysfunction.
Why it matters
Potential benefit: If successful, this approach could lead to improved blood pressure management during liver transplantation, enhancing patient outcomes.
How similar studies have performed: Other studies have shown success with Angiotensin II in treating vasodilatory shock, suggesting potential for this novel application in liver transplantation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Michael P Bokoch, M.D., Ph.D. — Department of Anesthesia and Perioperative Care, University of California, San Francisco
- Study coordinator: Michael P Bokoch, M.D., Ph.D.
- Email: michael.bokoch@ucsf.edu
- Phone: (415) 476-8389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.