Ignite Creation Date:
2024-05-06 @ 8:23 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02727296
Status:
UNKNOWN
Last Update Posted:
2020-05-08
First Post:
2016-03-23
Brief Title:
Volatile Anesthetic Protection Of Renal Transplants 2
Sponsor:
Gertrude J Nieuwenhuijs-Moeke
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Volatile Anesthetic Protection Of Renal Transplants 2
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAPOR-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 urineplasma mechanisms of protectionimmunomodulation with anestheticanaesthetic agents
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 urineplasma mechanisms of protectionimmunomodulation with anestheticanaesthetic agents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None