Low-dose vasopressin to prevent acute kidney injury after liver transplant
Effect of Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation
This study tests whether giving low-dose vasopressin during liver transplant surgery can reduce acute kidney injury in adults scheduled for a liver transplant.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06344442 on ClinicalTrials.gov |
What this trial studies
AVENIR is a prospective, national, multicenter, double-blind, randomized Phase 3 trial comparing intraoperative low-dose arginine‑vasopressin to norepinephrine in two parallel arms. Study drug infusions are started at 5 ml/h and titrated to maintain a mean arterial pressure of at least 65 mmHg, with vasopressin doses of 0.01–0.06 U/min versus norepinephrine 10–60 µg/min. The primary objective is to see if vasopressin supplementation reduces the incidence of post‑transplant acute kidney injury. The trial excludes simultaneous liver‑kidney transplants and patients with end‑stage renal disease and requires informed consent from adults undergoing scheduled liver transplantation.
Who should consider this trial
Good fit: Adults aged 18 or older who are scheduled for an isolated liver transplant, can give informed consent, and do not have end‑stage renal disease or a plan for simultaneous liver‑kidney transplant are ideal candidates.
Not a fit: Patients undergoing super‑emergency or fulminant hepatitis transplants, those listed for or receiving simultaneous liver‑kidney transplantation, those with end‑stage renal disease, pregnant or breastfeeding people, or those with vasopressin hypersensitivity are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower the rate of acute kidney injury after liver transplant, reducing the need for dialysis and improving short‑ and long‑term outcomes.
How similar studies have performed: Physiologic data and small clinical studies suggest vasopressin may preferentially protect renal function, but large randomized trials specifically in liver transplantation are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 * Pregnancy or breastfeeding
Where this trial is running
Paris
- URC Lariboisière-Fernand Widal-saint Louis — Paris, France (Recruiting)
Study contacts
- Principal investigator: Gilles LEBUFFE, Pr — Service Anesthésie-Réanimation - CHU de Lille
- Study coordinator: Jacques DURANTEAU, Pr
- Email: jacques.duranteau@aphp.fr
- Phone: 01 45 21 34 41
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.