Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Albumin administration.
- Who it may be relevant to
- Registry conditions: Liver Transplantation, Acute Kidney Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)).
Interventions
- Drug Albumin administration
when albumin serum concentration is at 30 g/L or below
Primary outcome measures
- Acute Kindey Injury at Day 7 [Time frame: 7 days after liver transplantation]
Secondary outcome measures (12)
- 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 [Time frame: 28 days]
- duration of mechanical ventilation [Time frame: 28 days]
- reintubation rate [Time frame: 28 days]
- Intensive Care Unit length of stay [Time frame: 28 days]
- Intensive Care Unit readmission rate [Time frame: 28 days]
- All cause mortality [Time frame: 28 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 8 centers
- 08_CHRU de Tours Hôpital Trousseau — Chambray-lès-Tours
- 03_APHP Hôpital Beaujon — Clichy
- 04_CHU de Lille Hôpital Huriez — Lille
- 05_HCL Hôpital de la Croix Rousse — Lyon
- 06_CHU de Montpellier Hôpital St Eloi — Montpellier
- 02_CHU de Bordeaux - Hôpital Haut Leveque — Pessac
- 01_CHU de Rennes Hôpital Pontchaillou — Rennes
- 09_APHP Hôpital Paul Brousse — Villejuif
Identifiers
NCT: NCT06535945 · 35RC22_9739_HALT · 2024-514804-14-00