Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial)

Summary

Liver transplantation (LT) is a high-risk surgery for hemodynamic instability and haemorrhagic shock with a high-risk of acute kidney injury (AKI). Indeed, the incidence of post-transplant AKI exceeds 50% in some series with 15% of patients requiring renal replacement therapy. Acute kidney injury after LT is a predisposing factor for chronic renal failure which is independently associated with higher morbidity and mortality.

Arginine vasopressin (AVP), an essential stress hormone released in response to hypotension, binds to AVPR1a to promote vasoconstriction. Furthermore, it may have nephroprotective effects with a preferential vasoconstriction of the post-glomerular arteriole resulting in increased glomerular filtration

The hypothesis of the present work is that low-dose arginine-vasopressin supplementation reduce posttransplant AKI in liver transplantation.

Conditions

• Acute Kidney Injury Post Liver Transplantation

Interventions

DRUG

Arginine vasopressin

low-dose arginine-vasopressin supplementation group: Vasopressin will be administered by continuous infusion. AVP will be used to a final concentration of 0.12 U/ml. The vasopressor infusion will be titrated to maintain an MAP of at least 65 mmHg. The study-drug infusion will be started at 5 ml/h and increased by 2.5 ml/h to achieve a maximum target rate of 30 ml/h, so that AVP doses ranged from 0.01 to 0.06 U/min.

DRUG

Norepinephrine

Norepinephrine will be administered by continuous infusion. Norepinephrine will be used with final concentrations of 120 microg/ml. The vasopressor infusion will be titrated to maintain an MAP of at least 65 mmHg. The study-drug infusion will be started at 5 ml/h and increased by 2.5 ml/h to achieve a maximum target rate of 30 ml/h, so that NE doses ranged from10 to 60 microg/min.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Jacques DURANTEAU, Pr · Département Anesthésie-Réanimation - Université Paris-Saclay Hospital Bicêtre - Paul Brousse

• Gilles LEBUFFE, Pr · Service Anesthésie-Réanimation - CHU de Lille

• Daniel EYRAUD, Pr · Service Anesthésie-Réanimation -APHP Pitié-Salpêtrière

• Emmanuel WEISS, Pr · Service Anesthésie-Réanimation - APHP hôpital Beaujon

• Antoine DEWITTE, Pr · Service Anesthésie-Réanimation -CHU de Bordeaux centre médicochirurgical Magellan hôpital Haut Lévêque

• Baptiste LORDIER, Pr · Service Anesthésie-Réanimation -CHU de Strasbourg Hôpital de Hautepierre

• Alice BLET, Pr · Service Anesthésie-Réanimation - Hôpital de la Croix Rousse

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-16

Primary Completion

2025-05-16

Completion

2027-05-16

Countries

• France

Study Locations