Delayed Graft FunctionPhase 4VAPOR-2NCT02727296
Volatile Anesthetic Protection Of Renal Transplants 2
A Phase 4 study testing sevoflurane and propofol in people with Delayed Graft Function and Renal Outcome After Kidney Transplantation, run by University Medical Center Groningen at 5 sites in 4 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function, Renal Outcome After Kidney Transplantation, Acute Rejection (AR) of Transplanted Kidney
- What is being tested?
- sevoflurane and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Apr 2017to 31 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Written informed consent
Who cannot join
- high immunological risk as determined bij local practice
- Patients of the ABO-incompatible program
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Netherlands2 sites
Amsterdam University Medical Center
Amsterdam
University Medical Center Groningen
Groningen, Provincie Groningen, 9728XR
About this study
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
Read the 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:
Primary outcome: The two co-primary endpoints are the incidence of DGF and one-year acute rejection in recipients of DCD and DBD donor kidneys. DGF is defined as need for dialysis within the first week after transplantation, excluding one-time dialysis for hyperkalaemia. Acute rejection is defined by the modified BANFF 2013 classification and must be associated with decline in kidney function and treatment.
Secondary outcomes Functional delayed graft function (fDGF) is defined as the absence of a daily decrease of at least 10% in serum creatinine for at least three consecutive days; primary non function (PNF) defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kind (28). Estimated glomerular filtration rate (eGFR) at one week and three and twelve months calculated with the CKD-EPI formula; measured GFR employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo) at twelve months; readmissions at three and twelve months, graft survival and patient survival at twelve months.;
The investigators predefined four substudies being: Cardiac biomarkers in renal transplantation, Volatile vs Intravenous anaesthetic agent; 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; Association between intraoperative haemodynamics and vasopressor use and graft outcome; Postoperative delirium, volatile vs Intravenous anaesthetic agent (Groningen, Aarhus);
- Conditions
- Delayed Graft Function, Renal Outcome After Kidney Transplantation, Acute Rejection (AR) of Transplanted Kidney, Graft Survival, Patient Survival, Postoperative Complications
- Being tested
- sevoflurane, propofol
- Keywords
- anesthesiology, sevoflurane, propofol, kidney transplantation
- Medical subject headings
- Delayed Graft Function, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneDrug
General anesthesia with sevoflurane
propofolDrug
General anesthesia with propofol
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | Group 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia. Receives: Drug: propofol |
| sevoflurane | Active comparator | Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia. Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: DGF: 7 days after transplantation Acute rejection: up to 1 year after transplantation
Secondary outcomes (9)
Estimated Glomerular Filtration Rate (GFR)
calculated with the CKD-EPI formula
Measured: 7 days after transplantation, 3 months after transplantation, 1 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
Measured: up to 3 months after transplantation
Incidence of funactional Delayed Graft Function
Absence of a daily decrease of at least 10% in serum creatinine for at least three consecutive days
Measured: 7 days after transplantation
Length of hospital stay
Days
Measured: From day of transplantation until the day of discharge, assessed up to 60 days
Postoperative complications of all kind
Measured: from the day of transplantation until the day of discharge, assessed up to 60 days
hospital readmissions after transplantation
Measured: 3 months after transplantation and between 3 months and 1year after transplantation
Graft survival
Measured: up to 1 year after transplantation
All-cause mortality
Mortality due to any cause
Measured: up to 1 year after transplantation
measured GFR employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo) at twelve months
In a subpopulation of Groningen, Aarhus, Oslo; employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo)
Measured: 1 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start1 Apr 2017
- Primary completion30 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gertrude J. Nieuwenhuijs-Moeke, MD PhD, University Medical Center Groningen
- Investigators
- Gertrude J Nieuwenhuijs-Moeke, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727296
- Sponsor's protocol ID
- VAPOR-002
- Acronym
- VAPOR-2
- Status last verified
- Jul 2025
- First submitted
- 23 Mar 2016
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study and primary data analysis, the dataset will be anonymized and made openly accessible through a public data repository
Publications
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.
PubMed 40897490
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatile Anesthetic Protection Of Renal Transplants 2
- ClinicalTrials.gov ID
- NCT02727296
- Acronym / sponsor ID
- VAPOR-2 / VAPOR-002
- Conditions
- Delayed Graft Function, Renal Outcome After Kidney Transplantation, Acute Rejection (AR) of Transplanted Kidney, Graft Survival, Patient Survival, Postoperative Complications
- Keywords
- anesthesiology, sevoflurane, propofol, kidney transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Primary outcome: The two co-primary endpoints are the incidence of DGF and one-year acute rejection in recipients of DCD and DBD donor kidneys. DGF is defined as need for dialysis within the first week after transplantation, excluding one-time dialysis for hyperkalaemia. Acute rejection is defined by the modified BANFF 2013 classification and must be associated with decline in kidney function and treatment.
Secondary outcomes Functional delayed graft function (fDGF) is defined as the absence of a daily decrease of at least 10% in serum creatinine for at least three consecutive days; primary non function (PNF) defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kind (28). Estimated glomerular filtration rate (eGFR) at one week and three and twelve months calculated with the CKD-EPI formula; measured GFR employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo) at twelve months; readmissions at three and twelve months, graft survival and patient survival at twelve months.;
The investigators predefined four substudies being: Cardiac biomarkers in renal transplantation, Volatile vs Intravenous anaesthetic agent; 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; Association between intraoperative haemodynamics and vasopressor use and graft outcome; Postoperative delirium, volatile vs Intravenous anaesthetic agent (Groningen, Aarhus);
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: propofolGroup 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia. |
| sevoflurane | Active comparator | Drug: sevofluraneGroup 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Written informed consent
Key exclusion criteria (2 listed)
- high immunological risk as determined bij local practice
- Patients of the ABO-incompatible program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sevofluraneGeneral anesthesia with sevoflurane | Drug | sevoflurane |
| propofolGeneral anesthesia with propofol | Drug | propofol |
Primary outcome
Incidence of delayed graft function and/or one year acute rejection
Time frame: DGF: 7 days after transplantation Acute rejection: up to 1 year after transplantation
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.
9 secondary outcomes
Estimated Glomerular Filtration Rate (GFR)
Time frame: 7 days after transplantation, 3 months after transplantation, 1 year after transplantation
incidence of primary non function (PNF)
Time frame: up to 3 months after transplantation
Incidence of funactional Delayed Graft Function
Time frame: 7 days after transplantation
Length of hospital stay
Time frame: From day of transplantation until the day of discharge, assessed up to 60 days
Postoperative complications of all kind
Time frame: from the day of transplantation until the day of discharge, assessed up to 60 days
hospital readmissions after transplantation
Time frame: 3 months after transplantation and between 3 months and 1year after transplantation
Graft survival
Time frame: up to 1 year after transplantation
All-cause mortality
Time frame: up to 1 year after transplantation
measured GFR employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo) at twelve months
Time frame: 1 year after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 40897490Huisman 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.
- Individual participant dataSharing planned: Yes. Upon completion of the study and primary data analysis, the dataset will be anonymized and made openly accessible through a public data repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gertrude J Nieuwenhuijs-Moeke, MD principal investigator
University Medical Center Groningen
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sevoflurane and propofol in people with Delayed Graft Function and Renal Outcome After Kidney Transplantation, run by University Medical Center Groningen at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Denmark, Norway, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delayed graft function and/or one year acute rejection (time frame: DGF: 7 days after transplantation Acute rejection: up to 1 year after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.