A Phase 4 interventional study of Sevoflurane in Post-transplantation Liver Allograft Function, sponsored by University of Liege. Status unknown at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2015-01-21.
Sponsored by University of Liege · Phase 4, Interventional, and Treatment
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.
University of Liege is the lead sponsor of 250 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1 MAC of sevoflurane for 15 minutes before organs procurement.
Drug: Sevoflurane
No volatile anesthetics during organs procurement
In the sevoflurane group, the anesthetic agent has to be administered immediately after arrival in the operating room to reach an end-expiratory target concentration of 2%. This concentration of sevoflurane should be maintained until the procedural cardiac arrest and for at least 15 min.
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.
Time frame: First week post-transplantation
• Incidence of primary non function (liver failure requiring emergent re-transplantation)
Time frame: 30-day and 6-month after transplantation.
• Hospital length of stay.
Time frame: 30-day and 6-month after transplantation.
• Allograft function (yes/no) at 30-day and 6-month after transplantation.
Time frame: 30-day and 6-month after transplantation.
• Hospital mortality and at 30-day.
Time frame: 30-day.
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.
Time frame: First week after transplantation, 30 day and 6-month.
• 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.
Time frame: First week after transplantation, 30 day and 6-month.
• Length of delayed graft function.
Time frame: First week after transplantation, 30 day and 6-month.
• 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.
Time frame: First week after transplantation, 30 day and 6-month.
• Hospital length of stay.
Time frame: First week after transplantation, 30 day and 6-month.
• Hospital mortality and mortality at 30-day.
Time frame: First week after transplantation, 30 day and 6-month.
The record gives a start of Jan 2015 and a primary completion of Dec 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sevoflurane