Acute Kidney Injury, Liver Transplantation
Conditions
Keywords
Liver, Transplantation, Albumin, Acute Kidney Injury
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)).
Interventions
DRUGAlbumin administration
when albumin serum concentration is at 30 g/L or below
Sponsors
Rennes University Hospital
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| hospital length of stay | 28 days | hospital length of stay |
| occurrence of calcineurin inhibitor induced neurotoxicity | 28 days | occurrence of calcineurin inhibitor induced neurotoxicity |
| occurence of calcineurin inhibitor withdraw | 28 days | occurence of calcineurin inhibitor withdraw |
| occurrence of postoperative infections | 28 days | occurrence of postoperative infections |
| occurrence of acute graft rejection | 28 days | occurrence of acute graft rejection |
| 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 |
| 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 |
| All cause mortality | 28 days | All cause mortality |
Countries
France
Contacts
CONTACTLoïc JACOB
PRINCIPAL_INVESTIGATORPauline HOUSSEL-DEBRY, MD
Rennes University Hospital
Outcome results
None listed