Volatile Anesthetic Protection Of Renal Transplants 2 (VAPOR-2)

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 4

Conditions: Length of Hospital Stay; Postoperative Complications; Patient Survival; Primary Non Function; Acute Rejection (AR) of Transplanted Kidney; Renal Outcome After Kidney Transplantation; Delayed Graft Function; Graft Survival

Treatments: Drug: propofol; Drug: sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02727296

VAPOR-002

Details and patient eligibility

About

To compare the effect of a sevoflurane based anesthesia versus a propofol based anesthesia on the incidence of DGF in recipients of kidneys of donation after circulatory death (DCD) and donation after brain death (DBD) donors

Full 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);

Enrollment: 488 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Written informed consent

Exclusion criteria

• high immunological risk as determined bij local practice
• Patients of the ABO-incompatible program

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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488 participants in 2 patient groups

propofol

Active Comparator group

Description:

Group 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia.

Treatment:

Drug: propofol

sevoflurane

Active Comparator group

Description:

Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia.

Treatment:

Drug: sevoflurane