Clinical trial NCT06535945: Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
Official title: Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liver Transplantation
Acute Kidney Injury
Keywords: Liver
Transplantation
Albumin
Acute Kidney Injury
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2024-08-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)).


Eligibility criteria: 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

Primary outcomes:
measure: Acute Kindey Injury at Day 7
timeFrame: 7 days after liver transplantation
Secondary outcomes:
measure: Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation
timeFrame: 7 days after liver transplantation
measure: hospital length of stay
timeFrame: 28 days
measure: occurrence of calcineurin inhibitor induced neurotoxicity
timeFrame: 28 days
measure: occurence of calcineurin inhibitor withdraw
timeFrame: 28 days
measure: occurrence of postoperative infections
timeFrame: 28 days
measure: occurrence of acute graft rejection
timeFrame: 28 days
measure: occurrence of early graft dysfunction
timeFrame: 28 days
measure: duration of mechanical ventilation
timeFrame: 28 days
measure: reintubation rate
timeFrame: 28 days
measure: Intensive Care Unit length of stay
timeFrame: 28 days
measure: Intensive Care Unit readmission rate
timeFrame: 28 days
measure: All cause mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Chambray-les-tours
country: France
facility: 08_CHRU de Tours Hôpital Trousseau
city: Clichy
country: France
facility: 03_APHP Hôpital Beaujon
city: Lille
country: France
facility: 04_CHU de Lille Hôpital Huriez
city: Lyon
country: France
facility: 05_HCL Hôpital de la Croix Rousse
city: Montpellier
country: France
facility: 06_CHU de Montpellier Hôpital St Eloi
city: Pessac
country: France
facility: 02_CHU de Bordeaux - Hôpital Haut Leveque
city: Rennes
country: France
facility: 01_CHU de Rennes Hôpital Pontchaillou
city: Villejuif
country: France
facility: 09_APHP Hôpital Paul Brousse
Study officials:
affiliation: CHU Rennes
name: Pauline HOUSSEL-DEBRY, MD
role: PRINCIPAL_INVESTIGATOR
References: