Volatile Anesthetic Protection Of Renal Transplants 2

Brief Summary

Detailed Description

Objective: To compare the effect of a sevoflurane based anaesthesia versus a propofol based anaesthesia on the incidence of delayed graft function in recipients of DCD and DBD donor kidneys. Study design: Prospective randomized controlled European multicentre clinical trial with two parallel groups Study population: Patients ≥18 years scheduled for kidney transplantation with a kidney from a DBD or DCD donor Intervention: Patients will be included and randomised to one of the following groups: Group 1 PROP (control): Propofol: a propofol-remifentanil based anaesthesia. Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based anaesthesia. Main study parameters: Primary outcome: The two co-primary endpoints are the incidence of DGF and one-year acute rejection in recipients of DCD and DBD donor kidneys. DGF is defined as need for dialysis within the first week after transplantation, excluding one-time dialysis for hyperkalaemia. Acute rejection is defined by the modified BANFF 2013 classification and must be associated with decline in kidney function and treatment. Secondary outcomes Functional delayed graft function (fDGF) is defined as the absence of a daily decrease of at least 10% in serum creatinine for at least three consecutive days; primary non function (PNF) defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kind (28). Estimated glomerular filtration rate (eGFR) at one week and three and twelve months calculated with the CKD-EPI formula; measured GFR employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo) at twelve months; readmissions at three and twelve months, graft survival and patient survival at twelve months.; The investigators predefined four substudies being: Cardiac biomarkers in renal transplantation, Volatile vs Intravenous anaesthetic agent; Predictive value of urinary Biomarkers in a deceased donor kidney transplantation cohort to predict PNF, DGF, Acute rejection and long term graft function and outcome; Association between intraoperative haemodynamics and vasopressor use and graft outcome; Postoperative delirium, volatile vs Intravenous anaesthetic agent (Groningen, Aarhus);

Primary Outcomes

Secondary Outcomes

• incidence of primary non function (PNF)(up to 3 months after transplantation)
• Estimated Glomerular Filtration Rate (GFR)(7 days after transplantation, 3 months after transplantation, 1 year after transplantation)
• Incidence of funactional Delayed Graft Function(7 days after transplantation)
• Length of hospital stay(From day of transplantation until the day of discharge, assessed up to 60 days)
• Postoperative complications of all kind(from the day of transplantation until the day of discharge, assessed up to 60 days)
• hospital readmissions after transplantation(3 months after transplantation and between 3 months and 1year after transplantation)
• Graft survival(up to 1 year after transplantation)
• All-cause mortality(up to 1 year after transplantation)
• measured GFR employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo) at twelve months(1 year after transplantation)