Kidney Donation/TransplantationNCT01248871
"Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail
A study testing procedure:sevoflurane-remifentanil/sufentanil, volatile agent only during reperfusion and propofol-remifentanil/sufentanil in people with Kidney Donation/Transplantation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
To compare the renal protective properties of two currently used anaesthetic techniques - a sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil combination for anaesthesia in patients undergoing living donor kidney donation/transplantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Donation/Transplantation
- What is being tested?
- procedure:sevoflurane-remifentanil/sufentanil, volatile agent only during reperfusion and propofol-remifentanil/sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to Oct 2012
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients: Age > 18 years
Who cannot join
- patient refusal
- BMI< 17, >35
- neurological disorder
- recent use of psycho-active medication, including alcohol.
- Donor-recipient couples from the ABO-incompatible program
- Altruistic donor
Trial locations and contacts
1 site in 1 country.
About this study
To compare the renal protective properties of two currently used anaesthetic techniques - a sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil combination for anaesthesia in patients undergoing living donor kidney donation/transplantation.
- Conditions
- Kidney Donation/Transplantation
- Being tested
- procedure:sevoflurane-remifentanil/sufentanil, volatile agent only during reperfusion, propofol-remifentanil/sufentanil
- Keywords
- renal, transplantation, Volatile, anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procedure:sevoflurane-remifentanil/sufentanilDrug
Active Comparator
volatile agent only during reperfusionDrug
Active Comparator
propofol-remifentanil/sufentanilDrug
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| SEVO | Active comparator | sevoflurane-remifentanil/sufentanil combination Receives: Drug: procedure:sevoflurane-remifentanil/sufentanil |
| SERE | Active comparator | volatile agent only during reperfusion Receives: Drug: volatile agent only during reperfusion |
| propofol | Active comparator | propofol-remifentanil/sufentanil Receives: Drug: propofol-remifentanil/sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the renal protective properties of two currently used anaesthetic techniques
Measured: participants will be followed for the duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2012
- Study completionOct 2012
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 Kidney Donation/TransplantationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M.M.R.F Struys, Prof.dr., Principal investigator, University Medical Center GroningenR,J. Ploeg, Prof.dr, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248871
- Sponsor's protocol ID
- VAPOR 001
- Status last verified
- Apr 2024
- First submitted
- 24 Nov 2010
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Nieuwenhuijs-Moeke GJ, Nieuwenhuijs VB, Seelen MAJ, Berger SP, van den Heuvel MC, Burgerhof JGM, Ottens PJ, Ploeg RJ, Leuvenink HGD, Struys MMRF. Propofol-based anaesthesia versus sevoflurane-based anaesthesia for living donor kidney transplantation: results of the VAPOR-1 randomized controlled trial. Br J Anaesth. 2017 May 1;118(5):720-732. doi: 10.1093/bja/aex057.
PubMed 28510740
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail
- ClinicalTrials.gov ID
- NCT01248871
- Acronym / sponsor ID
- VAPOR 001
- Conditions
- Kidney Donation/Transplantation
- Keywords
- renal, transplantation, Volatile, anesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Nov 2010 (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 renal protective properties of two currently used anaesthetic techniques - a sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil combination for anaesthesia in patients undergoing living donor kidney donation/transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SEVO | Active comparator | Drug: procedure:sevoflurane-remifentanil/sufentanilsevoflurane-remifentanil/sufentanil combination |
| SERE | Active comparator | Drug: volatile agent only during reperfusionvolatile agent only during reperfusion |
| propofol | Active comparator | Drug: propofol-remifentanil/sufentanilpropofol-remifentanil/sufentanil |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients: Age > 18 years
Key exclusion criteria (6 listed)
- patient refusal
- BMI< 17, >35
- neurological disorder
- recent use of psycho-active medication, including alcohol.
- Donor-recipient couples from 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 |
|---|---|---|
| procedure:sevoflurane-remifentanil/sufentanilActive Comparator | Drug | SEVO |
| volatile agent only during reperfusionActive Comparator | Drug | SERE |
| propofol-remifentanil/sufentanilActive Comparator | Drug | propofol |
Primary outcome
To compare the renal protective properties of two currently used anaesthetic techniques
Time frame: participants will be followed for the duration of hospital stay
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 18 Apr 2024.
- Derived from this study: PubMed 28510740Nieuwenhuijs-Moeke GJ, Nieuwenhuijs VB, Seelen MAJ, Berger SP, van den Heuvel MC, Burgerhof JGM, Ottens PJ, Ploeg RJ, Leuvenink HGD, Struys MMRF. Propofol-based anaesthesia versus sevoflurane-based anaesthesia for living donor kidney transplantation: results of the VAPOR-1 randomized controlled trial. Br J Anaesth. 2017 May 1;118(5):720-732. doi: 10.1093/bja/aex057.
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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.
M.M.R.F Struys, Prof.dr. principal investigator
University Medical Center Groningen
R,J. Ploeg, Prof.dr principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procedure:sevoflurane-remifentanil/sufentanil, volatile agent only during reperfusion and propofol-remifentanil/sufentanil in people with Kidney Donation/Transplantation, run by University Medical Center Groningen at 1 site in Netherlands.
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 1 inclusion and 6 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 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
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?
To compare the renal protective properties of two currently used anaesthetic techniques (time frame: participants will be followed for the duration of hospital stay). 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 NCT01248871, 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 18 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.