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

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ClinicalTrials.gov Identifier: NCT02727296
Recruitment Status : Recruiting
First Posted : April 4, 2016
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Gertrude J. Nieuwenhuijs-Moeke, University Medical Center Groningen

Tracking Information
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
 (submitted: November 9, 2017)
incidence of delayed graft function [ Time Frame: during first week after transplantation ]
DGF is defined as need of dialysis first 7 days after transplantation
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
  • Glomerular Filtration Rate (GFR) [ Time Frame: 3, 6 and 12 months ]
    GFR will be calculated with the use of a 24h creatinin clearance in urine
  • Acute rejection [ Time Frame: during first year after transplantation ]
    biopsy proven with decline in kidney function and therapy needed
  • incidence of primary non function (PNF) [ Time Frame: first three months after transplantation ]
    PNF is defined as permanent lack of function of the transplanted kidney. This kidney will not gain function after transplantation
  • kidney injury urinary biomarkers [ Time Frame: first week after transplantation ]
    a set of kidney urinary biomarkers will be measured in urinary samples
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
  • Glomerular Filtration Rate (GFR) [ Time Frame: 3, 6 and 12 months ]
    GFR will be calculated with the use of a 24h creatinin clearance in urine
  • incidence of delayed graft function (DGF) [ Time Frame: first week after transplantation ]
    DGF is defined as the need of dialysis the first week after transplantation
  • incidence of primary non function (PNF) [ Time Frame: first three months after transplantation ]
    PNF is defined as permanent lack of function of the transplanted kidney. This kidney will not gain function after transplantation
  • kidney injury urinary biomarkers [ Time Frame: first week after transplantation ]
    a set of kidney urinary biomarkers will be measured in urinary samples
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Delayed Graft Function
  • Renal Outcome After Kidney Transplantation
Intervention  ICMJE
  • Drug: sevoflurane
    General anesthesia with sevoflurane
  • Drug: propofol
    General anesthesia with propofol
Study Arms  ICMJE
  • Active Comparator: propofol
    Group 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia.
    Intervention: Drug: propofol
  • Active Comparator: sevoflurane
    Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia.
    Intervention: Drug: sevoflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2017)
488
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2016)
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:

  • Age > 18 years
  • Written informed consent

Exclusion Criteria:

  • high immunological risk as determined bij local practice
  • Patients of the ABO-incompatible program
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gertrude J Nieuwenhuijs-Moeke, MD +31631623075 g.j.nieuwenhuijs-moeke@umcg.nl
Contact: Rob Spanjersberg +31503611158 r.spanjersberg@umcg.nl
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gertrude J. Nieuwenhuijs-Moeke, University Medical Center Groningen
Study Sponsor  ICMJE Gertrude J. Nieuwenhuijs-Moeke
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gertrude J Nieuwenhuijs-Moeke, MD University Medical Center Groningen
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