Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04901169
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2021-05-20
Brief Title:
Angiotensin II in Liver Transplantation
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Angiotensin II in Liver Transplantation AngLT-1 A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AngLT-1
Brief 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
Detailed Description:
This is a single center randomized double-blind placebo-controlled trial Subjects will receive an infusion of either Angiotensin II AngII or a saline control placebo in addition to usual care with traditional vasopressors catecholamines and vasopressin during liver transplantation LT AngII is a vasopressor approved by the FDA for the treatment of vasodilatory shock It targets the renin-angiotensin system RAS and has been shown to effectively raise the mean arterial blood pressure MAP in patients with septic shock It also allows for lower doses of traditional vasopressors and may improve microcirculatory flow to the kidneys The study drug will only be administered if the participants require 005 mcgkgmin of norepinephrine while undergoing liver transplantation The study drug will be titrated throughout the case and discontinued at the end of surgery Randomization will be stratified based on a the need for renal replacement therapy preoperatively and b the use of normothermic machine perfusion of the liver graft
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None