Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation

Phase 4

Recruiting

• Conditions: Liver Transplantation; Acute 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

Study Timeline

• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Study First Posted: 2024-08-02
• Status Verified: 2025-03
• Study Start: 2025-03-26
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2028-04-26
• Study Completion: 2028-04-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

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
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
duration of mechanical ventilation	28 days	duration of mechanical ventilation
reintubation rate	28 days	reintubation rate
All cause mortality	28 days	All cause mortality
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

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