Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation (HALT)

Rennes University Hospital

Status and phase: Enrolling; Phase 4

Conditions: Liver Transplantation; Acute Kidney Injury

Treatments: Drug: Albumin administration

Study type: Interventional

Funder types: Other

Identifiers

NCT06535945

35RC22_9739_HALT

2024-514804-14-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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)).

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

30 g/L or below

Experimental group

Description:

Receive Human Albumin 20% Solution when albumin serum concentration is at 30 g/L or below

Treatment:

Drug: Albumin administration

20 g/L or below

Active Comparator group

Description:

receive Human Albumin 20% Solution when albumin serum concentration is at 20 g/L or below

Treatment:

Drug: Albumin administration