Study Results
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Basic Information
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COMPLETED
PHASE4
488 participants
INTERVENTIONAL
2017-04-01
2025-01-31
Brief Summary
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Detailed Description
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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);
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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propofol
Group 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia.
propofol
General anesthesia with propofol
sevoflurane
Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia.
sevoflurane
General anesthesia with sevoflurane
Interventions
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sevoflurane
General anesthesia with sevoflurane
propofol
General anesthesia with propofol
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Patients of the ABO-incompatible program
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Gertrude J. Nieuwenhuijs-Moeke, MD PhD
MD PhD
Principal Investigators
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Gertrude J Nieuwenhuijs-Moeke, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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Aarhus University Hospital
Aarhus, , Denmark
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Amsterdam University Medical Center
Amsterdam, , Netherlands
university Hospital Oslo
Oslo, , Norway
Fundagio Puigvert
Barcelona, , Spain
Countries
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References
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Huisman GJJ, Berger SP, Thyrrestrup PS, Hausken J, Veelo DP, Guirado L, Pol R, Jensen LL, Tonnessen TI, Bemelman FJ, Facundo C; VAPOR-2 STUDY GROUP; Tamasi K, Lunter G, Jespersen B, Leuvenink HGD, Struys MMRF, Nieuwenhuijs-Moeke GJ. Propofol-based versus sevoflurane-based anaesthesia for deceased donor kidney transplantation: the VAPOR-2 study protocol for an international multicentre randomised controlled trial. BMJ Open. 2025 Sep 2;15(9):e098965. doi: 10.1136/bmjopen-2025-098965.
Other Identifiers
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VAPOR-002
Identifier Type: -
Identifier Source: org_study_id
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