protocolSection identificationModule nctId: NCT06344442, orgStudyIdInfo id: APHP220827, briefTitle: Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2026-06-05, completionDateStruct date: 2026-06-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: 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 filtrationThe hypothesis of the present work is that low-dose arginine-vasopressin supplementation reduce posttransplant AKI in liver transplantation., conditionsModule conditions: Acute Kidney Injury Post Liver Transplantation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, national multicentre, double-blinded, randomized ,controlled superiority trial with two parallel arms, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All the clinical teams involved intraoperatively (anaesthetists, nurse anaesthetists and surgeons) and postoperatively (doctors and nurses who will take care of the patient postoperatively) and the families will ignore the allocation of treatments for the duration of the trial,except the nurse in charge of preparing the infusions ,She will ensure respect for the blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 304, type: ESTIMATED, armsInterventionsModule interventions name: Arginine vasopressin, interventions name: Norepinephrine, outcomesModule primaryOutcomes measure: The primary objective is to compare the effect of intraoperative low-dose supplementation of AVP vs norepinephrine infusions on post-transplant Acute Kidney Injury after liver transplantation., secondaryOutcomes measure: To compare into the two arms the number of packed red blood cellsand fresh frozen plasma transfused, secondaryOutcomes measure: To compare into the two arms the number of the Number of AKI KDIGO 1, secondaryOutcomes measure: To compare into the two arms the Number of AKI KDIGO 2, secondaryOutcomes measure: To compare into the Number of AKI KDIGO 3, secondaryOutcomes measure: The need for renal replacement for replacement therapy (RRT) in ICU, secondaryOutcomes measure: The number of patients remaining on dialysis at the end of the study, secondaryOutcomes measure: Average intraoperative norepinephrine concentrations, secondaryOutcomes measure: Average intraoperative concentrations of other vasopressors and inotropes (Adrenalin, Dobutamine), secondaryOutcomes measure: Number of platelets transfused intraoperatively, secondaryOutcomes measure: Amount of vascular filling solutions intraoperatively, secondaryOutcomes measure: Sequential Organ Failure Assessment (SOFA score), secondaryOutcomes measure: Number of days alive outside intensive care unit, secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: URC Lariboisière-Fernand Widal-saint Louis, city: Paris, zip: 75010, country: France, contacts name: Nabila PIZZI, role: CONTACT, phone: 01 40 05 49 83, phoneExt: +33, email: nabila.pizzi@aphp.fr, contacts name: Jaques DURANTEAU, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False