Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRennes University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Albumin administration
Drugwhen albumin serum concentration is at 30 g/L or below
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: 30 g/L or belowExperimental treatment 1 intervention
Group B: 20 g/L or belowActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Acute Kindey Injury at Day 7
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)).
Time frame
7 days after liver transplantationSecondary outcomes
1
Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation
Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation
Time frame
7 days after liver transplantation2
hospital length of stay
hospital length of stay
Time frame
28 days3
occurrence of calcineurin inhibitor induced neurotoxicity
occurrence of calcineurin inhibitor induced neurotoxicity
Time frame
28 days4
occurence of calcineurin inhibitor withdraw
occurence of calcineurin inhibitor withdraw
Time frame
28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rennes University Hospital
Lead sponsor
Ministry of Health, France
Collaborator
Source ClinicalTrials.gov