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

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

Study Overview

• Status: Unknown
• Conditions: Delayed Graft Function; Renal Outcome After Kidney Transplantation
• Intervention / Treatment: Drug: propofol; Drug: sevoflurane

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: Interventional
• Enrollment (Anticipated): 488
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gertrude J Nieuwenhuijs-Moeke, MD; Phone Number: +31631623075; Email: g.j.nieuwenhuijs-moeke@umcg.nl
• Study Contact Backup: Name: Rob Spanjersberg; Phone Number: +31503611158; Email: r.spanjersberg@umcg.nl

Study Locations

• Denmark
  • Aarhus, Denmark
    • Recruiting
    • Aarhus University Hospital
    • Contact: Luana L Jensen, MD
• Netherlands
  • Groningen, Netherlands, 9728XR
    • Recruiting
    • University Medical Center Groningen
    • Contact: Gertrude Nieuwenhuijs-Moeke, MD; Phone Number: +31631623075; Email: g.j.nieuwenhuijs-moeke@umcg.nl
    • Contact: Rob Spanjersberg; Phone Number: +31640365855; Email: r.spanjersberg@umcg.nl
• Spain
  • Barcelona, Spain
    • Recruiting
    • Fundagio Puigvert
    • Contact: Lluis G Perich, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years
• Written informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of delayed graft function	DGF is defined as need of dialysis first 7 days after transplantation	during first week after transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glomerular Filtration Rate (GFR)	GFR will be calculated with the use of a 24h creatinin clearance in urine	3, 6 and 12 months
Acute rejection	biopsy proven with decline in kidney function and therapy needed	during first year after transplantation
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
kidney injury urinary biomarkers	a set of kidney urinary biomarkers will be measured in urinary samples	first week after transplantation

Collaborators and Investigators

• Sponsor: Gertrude J. Nieuwenhuijs-Moeke
• Investigators: Principal Investigator: Gertrude J Nieuwenhuijs-Moeke, MD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (ESTIMATE): April 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Delayed Graft Function; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: VAPOR-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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