Effect of low-dose arginine-vasopressin supplementation on post-transplant Acute Kidney Injury after liver transplantation - AVENIR Trial

Phase 1

Conditions: Acute Kidney Injury, Liver transplantation
MedDRA version: 21.0Level: LLTClassification code: 10024716Term: Liver transplantation Class: 10042613
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
MedDRA version: 21.1Level: LLTClassification code: 10000821Term: Acute kidney failure Class: 10038359
Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Registration Number: CTIS2023-506512-40-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 304

Inclusion Criteria

Age = 18 years, Any adult patient with a scheduled liver transplantation, All participants will need to be given clear information about the study and give signed informed consent, Person affiliated to the Social Security

Exclusion Criteria

Super-emergency for liver transplantation or fulminant hepatitis, Pregnancy or breastfeeding, Patient listed for or receiving simultaneous liver-kidney transplantation (SLKT), Patients with end-stage renal disease (chronic eGFR < 15 mL/min/1.73 m2 or requiring extra-renal purification before liver transplantation, Patient with epilepsy, Hypersensitivity to arginine-vasopressin and to its excipients, Patient refusal, Patients for whom it is impossible to give informed consent (language barrier), Adults under guardianship or trusteeship, persons deprived of their liberty, Patient enrolled in another interventional clinical study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that intraoperative low-dose supplementation of AVP induces a reduction in post-transplant AKI after liver transplantation.;Secondary Objective: To compare the two arms in terms of number of packed red blood cells, platelets and fresh frozen plasma, vascular filling solutions transfused intraoperatively and during the first 12 hours postoperatively, need for renal replacement for replacement therapy (RRT) in ICU, average intraoperative norepinephrine and other vasopressors and inotropes concentrations sequential Organ Failure Assessment (SOFA score) on the third postoperative day length of stay in intensive care unit, and mortality at 30 days;Primary end point(s): Stages of AKI according to AKI Network criteria (KDIGO score) during the first 7 postoperative days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):The number of packed red blood cells and fresh frozen plasma transfused intraoperatively and during the first 12 hours postoperatively;Secondary end point(s):The need for renal replacement for replacement therapy (RRT) in ICU;Secondary end point(s):Average intraoperative norepinephrine concentrations;Secondary end point(s):Average intraoperative concentrations of other vasopressors and inotropes (Adrenalin, Dobutamine);Secondary end point(s):Number of platelets transfused intraoperatively and during the first 12 hours postoperatively;Secondary end point(s):Amount of vascular filling solutions intraoperatively and during the first 12 hours postoperatively;Secondary end point(s):Sequential Organ Failure Assessment (score SOFA) on the third postoperative day;Secondary end point(s):Number of days alive outside intensive care unit during the 30 day post-operation;Secondary end point(s):Mortality at 30 days