Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
- Conditions
- Liver TransplantationAcute Kidney Injury
- Interventions
- Drug: Albumin administration
- Registration Number
- NCT06535945
- Lead Sponsor
- Rennes University Hospital
- 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)).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 30 g/L or below Albumin administration Receive Human Albumin 20% Solution when albumin serum concentration is at 30 g/L or below 20 g/L or below Albumin administration receive Human Albumin 20% Solution when albumin serum concentration is at 20 g/L or below
- Primary Outcome Measures
Name Time Method Acute Kindey Injury at Day 7 7 days after liver transplantation 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)).
- Secondary Outcome Measures
Name Time Method Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation 7 days after liver transplantation Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation
occurrence of acute graft rejection 28 days occurrence of acute graft rejection
duration of mechanical ventilation 28 days duration of mechanical ventilation
Intensive Care Unit length of stay 28 days Intensive Care Unit length of stay
Intensive Care Unit readmission rate 28 days Intensive Care Unit readmission rate
hospital length of stay 28 days hospital length of stay
occurence of calcineurin inhibitor withdraw 28 days occurence of calcineurin inhibitor withdraw
occurrence of postoperative infections 28 days occurrence of postoperative infections
occurrence of calcineurin inhibitor induced neurotoxicity 28 days occurrence of calcineurin inhibitor induced neurotoxicity
occurrence of early graft dysfunction 28 days occurrence of early graft dysfunction
reintubation rate 28 days reintubation rate
All cause mortality 28 days All cause mortality
Trial Locations
- Locations (8)
08_CHRU de Tours Hôpital Trousseau
🇫🇷Chambray-les-tours, France
03_APHP Hôpital Beaujon
🇫🇷Clichy, France
04_CHU de Lille Hôpital Huriez
🇫🇷Lille, France
05_HCL Hôpital de la Croix Rousse
🇫🇷Lyon, France
06_CHU de Montpellier Hôpital St Eloi
🇫🇷Montpellier, France
02_CHU de Bordeaux - Hôpital Haut Leveque
🇫🇷Pessac, France
01_CHU de Rennes Hôpital Pontchaillou
🇫🇷Rennes, France
09_APHP Hôpital Paul Brousse
🇫🇷Villejuif, France
08_CHRU de Tours Hôpital Trousseau🇫🇷Chambray-les-tours, FranceEphrem SALAME, MDPrincipal Investigator