Volatile Anesthetic Protection Of Renal Transplants 2

NCT02727296 | Completed Phase 4 DMC

• 1 other identifier: VAPOR-002
• Study Type: interventional
• Target: 488
• Locations: 4 countries
• Sites: 5

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

Conditions

Delayed Graft Function; Renal Outcome After Kidney Transplantation; Acute Rejection (AR) of Transplanted Kidney; Graft Survival; Patient Survival; Postoperative Complications; Length of Hospital Stay; Primary Non Function

Keywords

anesthesiology; sevoflurane; propofol; kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Incidence of delayed graft function and/or one year acute rejection

  DGF is defined as need of dialysis first 7 days after transplantation Acute rejection up to 1 year after transplantation, defined by the modified BANFF 2013 classification and must be associated with decline in kidney function and treatment.

  DGF: 7 days after transplantation Acute rejection: up to 1 year after transplantation

Secondary Outcomes (9)

• Estimated Glomerular Filtration Rate (GFR)

  7 days after transplantation, 3 months after transplantation, 1 year after transplantation

• incidence of primary non function (PNF)

  up to 3 months after transplantation

• Incidence of funactional Delayed Graft Function

  7 days after transplantation

• Length of hospital stay

  From day of transplantation until the day of discharge, assessed up to 60 days

• Postoperative complications of all kind

  from the day of transplantation until the day of discharge, assessed up to 60 days

Other Outcomes (4)

• Cardiac biomarkers in renal transplantation, Volatile vs Intravenous anesthetic agent. A substudy of the VAPOR-2 study; a multicenter randomized controlled study

  From enrollment to 1 year follow-up

• Predictive value of urinary Biomarkers in a deceased donor kidney transplantation cohort to predict PNF, DGF, Acute rejection and long term graft function and outcome

  from enrollement to follow-up of 1 year

• Association between intraoperative haemodynamics and graft outcome

  from enrollement to 1 year follow-up

Study Arms (2)

propofol

ACTIVE COMPARATOR

Group 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia.

Drug: propofol

sevoflurane

ACTIVE COMPARATOR

Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia.

Drug: sevoflurane

Interventions

sevoflurane DRUG

General anesthesia with sevoflurane

sevoflurane

propofol DRUG

General anesthesia with propofol

propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (5)

Aarhus University Hospital

Aarhus, Denmark

Location

University Medical Center Groningen

Groningen, Provincie Groningen, 9728XR, Netherlands

Location

Amsterdam University Medical Center

Amsterdam, Netherlands

Location

university Hospital Oslo

Oslo, Norway

Location

Fundagio Puigvert

Barcelona, Spain

Location

Related Publications (1)

• Huisman GJJ, Berger SP, Thyrrestrup PS, Hausken J, Veelo DP, Guirado L, Pol R, Jensen LL, Tonnessen TI, Bemelman FJ, Facundo C; VAPOR-2 STUDY GROUP; Tamasi K, Lunter G, Jespersen B, Leuvenink HGD, Struys MMRF, Nieuwenhuijs-Moeke GJ. Propofol-based versus sevoflurane-based anaesthesia for deceased donor kidney transplantation: the VAPOR-2 study protocol for an international multicentre randomised controlled trial. BMJ Open. 2025 Sep 2;15(9):e098965. doi: 10.1136/bmjopen-2025-098965.

  PMID: 40897490 DERIVED

MeSH Terms

Conditions

Delayed Graft Function; Postoperative Complications

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Gertrude J Nieuwenhuijs-Moeke, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 4, 2016
• Study Start: April 1, 2017
• Primary Completion: January 30, 2025
• Study Completion: January 31, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study Protocol, ICF and SAP will be shared with the protocol article which will be publihed open access Upon completion of the study and primary data analysis, the dataset will be anonymized and made openly accessible through a public data repository (start date January 2027-end date to be determined)
• Access Criteria: all will be open access

Locations

NO (1); DK (1); ES (1); NL (2)