Volatile Anesthetic Protection Of Renal Transplants 2

Delayed Graft Function Clinical Trial

— VAPOR-2  

Official title:

Volatile Anesthetic Protection Of Renal Transplants 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02727296
• Other study ID #: VAPOR-002
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: December 2022

Study information

• Verified date: May 2020
• Source: University Medical Center Groningen
• Contact: Gertrude J Nieuwenhuijs-Moeke, MD
• Phone: +31631623075
• Email: g.j.nieuwenhuijs-moeke[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 488
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Written informed consent

Exclusion Criteria:

• high immunological risk as determined bij local practice

• Patients of the ABO-incompatible program

Related Conditions & MeSH terms

• Delayed Graft Function
• Renal Outcome After Kidney Transplantation

Intervention

Drug:
• sevoflurane
General anesthesia with sevoflurane
• propofol
General anesthesia with propofol

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Netherlands	University Medical Center Groningen	Groningen
Spain	Fundagio Puigvert	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Gertrude J. Nieuwenhuijs-Moeke

Countries where clinical trial is conducted

Denmark,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of delayed graft function	DGF is defined as need of dialysis first 7 days after transplantation	during first week after transplantation
Secondary	Glomerular Filtration Rate (GFR)	GFR will be calculated with the use of a 24h creatinin clearance in urine	3, 6 and 12 months
Secondary	Acute rejection	biopsy proven with decline in kidney function and therapy needed	during first year after transplantation
Secondary	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	first three months after transplantation
Secondary	kidney injury urinary biomarkers	a set of kidney urinary biomarkers will be measured in urinary samples	first week after transplantation