Volatile Anesthetic Protection Of Renal Transplants 2 (VAPOR-2)
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ClinicalTrials.gov Identifier: NCT02727296 |
Recruitment Status : Unknown
Verified May 2020 by Gertrude J. Nieuwenhuijs-Moeke, University Medical Center Groningen.
Recruitment status was: Recruiting
First Posted : April 4, 2016
Last Update Posted : May 8, 2020
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Tracking Information | |||||||
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First Submitted Date ICMJE | March 23, 2016 | ||||||
First Posted Date ICMJE | April 4, 2016 | ||||||
Last Update Posted Date | May 8, 2020 | ||||||
Actual Study Start Date ICMJE | April 1, 2017 | ||||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
incidence of delayed graft function [ Time Frame: during first week after transplantation ] DGF is defined as need of dialysis first 7 days after transplantation
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Original Primary Outcome Measures ICMJE |
incidence of acute rejection of the kidney allograft [ Time Frame: during a one year follow up ] Acute rejection will be defined as biopsy proven with decline in kidney function (as seen in rise of plasma creatinin levels) and therapy needed.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Volatile Anesthetic Protection Of Renal Transplants 2 | ||||||
Official Title ICMJE | Volatile Anesthetic Protection Of Renal Transplants 2 | ||||||
Brief Summary | 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 | ||||||
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: DGF defined as need of dialysis the first week after transplantation excluding one time dialysis for hyperkalemia Acute rejection episodes within the first year after transplantation Graft and patient survival GFR at 3 and 12 months PNF defined as a permanent lack of function of the allograft Length of hospital stay Postoperative complications of all kind kidney biomarkers (urine/plasma) mechanisms of protection/immunomodulation with anestheticanaesthetic agents |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
488 | ||||||
Original Estimated Enrollment ICMJE |
520 | ||||||
Estimated Study Completion Date ICMJE | December 2022 | ||||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Denmark, Netherlands, Spain | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02727296 | ||||||
Other Study ID Numbers ICMJE | VAPOR-002 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Gertrude J. Nieuwenhuijs-Moeke, University Medical Center Groningen | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Gertrude J. Nieuwenhuijs-Moeke | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University Medical Center Groningen | ||||||
Verification Date | May 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |