Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation

Phase 4RecruitingNCT06535945

Rennes University Hospital400 enrolled

Overview

To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (above 30 g/L) for five days diminishes rate of AKI at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Liver Transplantation Acute Kidney Injury

Interventions

Albumin administrationDRUG

when albumin serum concentration is at 30 g/L or below

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female subjects equal or above 18 yrs old. * Recipients of primary liver allografts from a deceased donor (including after cardiac death) and as a single organ (liver only). * Capability of understanding the purpose and risks of the study. * Written informed consent Exclusion Criteria: * Fulminant hepatitis * Kidney injury at baseline (Estimated Glomerular Filtration Rate \< 50 ml/min in Modification of diet in renal disease-6) including hepatorenal syndrome * Use of an induction agent Basiliximab at liver transplantation * Protected person (adults legally protected, under judicial protection, guardianship, or supervision), person deprived of their liberty * At the time of randomisation, participation to another interventional study

Locations (8)

08_CHRU de Tours Hôpital Trousseau

Chambray-lès-Tours, France

RECRUITING

03_APHP Hôpital Beaujon

Clichy, France

RECRUITING

04_CHU de Lille Hôpital Huriez

Lille, France

Outcomes

Primary Outcomes

Acute Kindey Injury at Day 7

To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (=30 g/L) for five days diminishes rate of Acute Kindey Injury at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).

Time frame: 7 days after liver transplantation

Secondary Outcomes

Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation

Time frame: 7 days after liver transplantation

hospital length of stay

Time frame: 28 days

occurrence of calcineurin inhibitor induced neurotoxicity

Time frame: 28 days

occurence of calcineurin inhibitor withdraw

Time frame: 28 days

occurrence of postoperative infections

Time frame: 28 days

occurrence of acute graft rejection

Time frame: 28 days

occurrence of early graft dysfunction

Central Contacts

Loïc JACOB

CONTACT

+33299282555 loic.jacob@chu-rennes.fr

Data from ClinicalTrials.gov

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