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

• ClinicalTrials.gov Identifier: NCT02727296
• Recruitment Status: Unknown
• First Posted: April 4, 2016
• Last Update Posted: May 8, 2020
• Sponsor: Gertrude J. Nieuwenhuijs-Moeke
• Information provided by (Responsible Party): Gertrude J. Nieuwenhuijs-Moeke, University Medical Center Groningen

Tracking Information

• First Submitted Date: March 23, 2016
• First Posted Date: April 4, 2016
• Last Update Posted Date: May 8, 2020
• Actual Study Start Date: April 1, 2017
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 9, 2017)

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 (submitted: April 1, 2016)

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.

Current Secondary Outcome Measures (submitted: November 9, 2017)

• 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 (submitted: April 1, 2016)

• 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: Volatile Anesthetic Protection Of Renal Transplants 2
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Delayed Graft Function
• Renal Outcome After Kidney Transplantation

Intervention

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 9, 2017): 488
• Original Estimated Enrollment (submitted: April 1, 2016): 520
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, Netherlands, Spain

Administrative Information

• NCT Number: NCT02727296
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Gertrude J. Nieuwenhuijs-Moeke, University Medical Center Groningen
• Original Responsible Party: Same as current
• Current Study Sponsor: Gertrude J. Nieuwenhuijs-Moeke
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gertrude J Nieuwenhuijs-Moeke, MD; University Medical Center Groningen

• PRS Account: University Medical Center Groningen
• Verification Date: May 2020