Document Type
Article
Publication Date
11-19-2023
Abstract
INTRODUCTION: Catecholamine vasopressors such as norepinephrine are the standard drugs used to maintain mean arterial pressure during liver transplantation. At high doses, catecholamines may impair organ perfusion. Angiotensin II is a peptide vasoconstrictor that may improve renal perfusion pressure and glomerular filtration rate, a haemodynamic profile that could reduce acute kidney injury. Angiotensin II is approved for vasodilatory shock but has not been rigorously evaluated for treatment of hypotension during liver transplantation. The objective is to assess the efficacy of angiotensin II as a second-line vasopressor infusion during liver transplantation. This trial will establish the efficacy of angiotensin II in decreasing the dose of norepinephrine to maintain adequate blood pressure. Completion of this study will allow design of a follow-up, multicentre trial powered to detect a reduction of organ injury in liver transplantation.
METHODS AND ANALYSIS: This is a double-blind, randomised clinical trial. Eligible subjects are adults with a Model for End-Stage Liver Disease Sodium Score ≥25 undergoing deceased donor liver transplantation. Subjects are randomised 1:1 to receive angiotensin II or saline placebo as the second-line vasopressor infusion. The study drug infusion is initiated on reaching a norepinephrine dose of 0.05 µg kg
ETHICS AND DISSEMINATION: The trial protocol was approved by the local Institutional Review Board (#20-30948). Results will be posted on ClinicalTrials.gov and published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: ClinicalTrials.govNCT04901169.
Recommended Citation
Bokoch, Michael; Tran, Amy; Brinson, Erika; Marcus, Sivan; Reddy, Meghana; Sun, Elizabeth; Roll, Garrett; Pardo, Manuel; Fields, Scott; Adelmann, Dieter; Kothari, Rishi; and Legrand, Matthieu, "Angiotensin II in liver transplantation (AngLT-1): protocol of a randomised, double-blind, placebo-controlled trial." (2023). Department of Anesthesiology Faculty Papers. Paper 88.
https://jdc.jefferson.edu/anfp/88
Creative Commons License
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PubMed ID
37984940
Language
English
Comments
This article is the author's final published version in BMJ Open, Volume 13, Issue 11, November 2023, Article number e078713.
The published version is available at https://doi.org/10.1136/bmjopen-2023-078713.
Copyright © Author(s) (or their employer(s)) 2023