Post-transplantation Liver Allograft Function Clinical Trial
The aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.
| Status | Not yet recruiting |
| Enrollment | 240 |
| Est. completion date | |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - all consecutive brain dead donors in the Belgian university hospitals of Leuven, Brussels, Louvain and Liège eligible for organs harvesting followed by organs transplantation in the Eurotransplant area. There is no age limitation for eligibility Exclusion Criteria: - haemodynamic instability that precludes safe administration of 2% sevoflurane. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Department of Anesthesiology, CHU Liège | Liège |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of Liege |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Composite outcome of post transplantation kidney function. | • Creatinine on the first post-transplantation blood test and on the following samples from the first to the 7th postoperative days. Maximal creatinine values and values at 72-hour after transplantation, the time for 50% decline, and the area under the curve during the first postoperative week. | First week after transplantation, 30 day and 6-month. | Yes |
| Other | • Delayed graft function : (defined as dialysis during first postop wk; decline in creatinine value | Dialysis during the first postoperative week. Decline in creatinine value of less than 10% per day during 3 consecutive days. |
First week after transplantation, 30 day and 6-month. | Yes |
| Other | • Length of delayed graft function. | First week after transplantation, 30 day and 6-month. | Yes | |
| Other | • Primary non function (patient who must go back to chronic hemodialysis and must be listed for re-transplantation | patient who must go back to chronic hemodialysis and must be listed for re-transplantation, at 30-day and 6-month after transplantation. | First week after transplantation, 30 day and 6-month. | Yes |
| Other | • Hospital length of stay. | First week after transplantation, 30 day and 6-month. | Yes | |
| Other | • Hospital mortality and mortality at 30-day. | First week after transplantation, 30 day and 6-month. | Yes | |
| Primary | Composite outcome of liver function following liver transplantation. | Transaminases, bilirubin, prothrombin time (PT) and international normalized ratio (INR) on the first post-transplantation blood test and on the following samples from the 1st to the 7th postoperative days. Number of liver recipients that will meet the criteria for "early allograft dysfunction" as defined by : bilirubin =10 mg/dL on the 7th day. INR = 1.6 on the 7th day. ALAT or ASAT > 2000 UI/L during the first 7 postoperative days. |
First week post-transplantation | Yes |
| Secondary | • Incidence of primary non function (liver failure requiring emergent re-transplantation) | 30-day and 6-month after transplantation. | Yes | |
| Secondary | • Hospital length of stay. | 30-day and 6-month after transplantation. | Yes | |
| Secondary | • Allograft function (yes/no) at 30-day and 6-month after transplantation. | 30-day and 6-month after transplantation. | Yes | |
| Secondary | • Hospital mortality and at 30-day. | 30-day. | Yes |