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

See Contacts and Locations

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

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

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

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

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

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:

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

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:

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

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