Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Delayed Graft Function Renal Outcome After Kidney Transplantation Drug: sevoflurane Drug: propofol Phase 4

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Volatile Anesthetic Protection Of Renal Transplants 2
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: propofol
Group 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia.
Drug: propofol
General anesthesia with propofol

Active Comparator: sevoflurane
Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia.
Drug: sevoflurane
General anesthesia with sevoflurane




Primary Outcome Measures :
  1. incidence of delayed graft function [ Time Frame: during first week after transplantation ]
    DGF is defined as need of dialysis first 7 days after transplantation


Secondary Outcome Measures :
  1. 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

  2. Acute rejection [ Time Frame: during first year after transplantation ]
    biopsy proven with decline in kidney function and therapy needed

  3. 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

  4. kidney injury urinary biomarkers [ Time Frame: first week after transplantation ]
    a set of kidney urinary biomarkers will be measured in urinary samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Written informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727296


Contacts
Layout table for location contacts
Contact: Gertrude J Nieuwenhuijs-Moeke, MD +31631623075 g.j.nieuwenhuijs-moeke@umcg.nl
Contact: Rob Spanjersberg +31503611158 r.spanjersberg@umcg.nl

Locations
Layout table for location information
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Luana L Jensen, MD         
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9728XR
Contact: Gertrude Nieuwenhuijs-Moeke, MD    +31631623075    g.j.nieuwenhuijs-moeke@umcg.nl   
Contact: Rob Spanjersberg    +31640365855    r.spanjersberg@umcg.nl   
Spain
Fundagio Puigvert Recruiting
Barcelona, Spain
Contact: Lluis G Perich, MD,PhD         
Sponsors and Collaborators
Gertrude J. Nieuwenhuijs-Moeke
Investigators
Layout table for investigator information
Principal Investigator: Gertrude J Nieuwenhuijs-Moeke, MD University Medical Center Groningen
Layout table for additonal information
Responsible Party: Gertrude J. Nieuwenhuijs-Moeke, MD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02727296    
Other Study ID Numbers: VAPOR-002
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Delayed Graft Function
Pathologic Processes
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation