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

Primary Purpose

Delayed Graft Function, Renal Outcome After Kidney Transplantation

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
sevoflurane
propofol
Sponsored by
Gertrude J. Nieuwenhuijs-Moeke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Graft Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aarhus University HospitalRecruiting
  • University Medical Center GroningenRecruiting
  • Fundagio PuigvertRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

propofol

sevoflurane

Arm Description

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

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

Outcomes

Primary Outcome Measures

incidence of delayed graft function
DGF is defined as need of dialysis first 7 days after transplantation

Secondary Outcome Measures

Glomerular Filtration Rate (GFR)
GFR will be calculated with the use of a 24h creatinin clearance in urine
Acute rejection
biopsy proven with decline in kidney function and therapy needed
incidence of primary non function (PNF)
PNF is defined as permanent lack of function of the transplanted kidney. This kidney will not gain function after transplantation
kidney injury urinary biomarkers
a set of kidney urinary biomarkers will be measured in urinary samples

Full Information

First Posted
March 23, 2016
Last Updated
May 7, 2020
Sponsor
Gertrude J. Nieuwenhuijs-Moeke
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1. Study Identification

Unique Protocol Identification Number
NCT02727296
Brief Title
Volatile Anesthetic Protection Of Renal Transplants 2
Acronym
VAPOR-2
Official Title
Volatile Anesthetic Protection Of Renal Transplants 2
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gertrude J. Nieuwenhuijs-Moeke

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Graft Function, Renal Outcome After Kidney Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
488 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
propofol
Arm Type
Active Comparator
Arm Description
Group 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia.
Arm Title
sevoflurane
Arm Type
Active Comparator
Arm Description
Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia.
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Description
General anesthesia with sevoflurane
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
General anesthesia with propofol
Primary Outcome Measure Information:
Title
incidence of delayed graft function
Description
DGF is defined as need of dialysis first 7 days after transplantation
Time Frame
during first week after transplantation
Secondary Outcome Measure Information:
Title
Glomerular Filtration Rate (GFR)
Description
GFR will be calculated with the use of a 24h creatinin clearance in urine
Time Frame
3, 6 and 12 months
Title
Acute rejection
Description
biopsy proven with decline in kidney function and therapy needed
Time Frame
during first year after transplantation
Title
incidence of primary non function (PNF)
Description
PNF is defined as permanent lack of function of the transplanted kidney. This kidney will not gain function after transplantation
Time Frame
first three months after transplantation
Title
kidney injury urinary biomarkers
Description
a set of kidney urinary biomarkers will be measured in urinary samples
Time Frame
first week after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gertrude J Nieuwenhuijs-Moeke, MD
Phone
+31631623075
Email
g.j.nieuwenhuijs-moeke@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Rob Spanjersberg
Phone
+31503611158
Email
r.spanjersberg@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gertrude J Nieuwenhuijs-Moeke, MD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luana L Jensen, MD
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9728XR
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gertrude Nieuwenhuijs-Moeke, MD
Phone
+31631623075
Email
g.j.nieuwenhuijs-moeke@umcg.nl
First Name & Middle Initial & Last Name & Degree
Rob Spanjersberg
Phone
+31640365855
Email
r.spanjersberg@umcg.nl
Facility Name
Fundagio Puigvert
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lluis G Perich, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Volatile Anesthetic Protection Of Renal Transplants 2

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