HealthyPhase 4NCT01132157
Comparison of the Protective Effect of Desflurane and Propofol in Patients With Renal Transplantation
A Phase 4 study testing Desflurane and Propofol in people with Healthy and End Stage Renal Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Ischemia/reperfusion (IR) injury is the major cause of early renal dysfunction and acute renal failure of the transplanted kidney after renal transplantation. In 1986, Murry et al. described the phenomenon "ischemic preconditioning". Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Healthy, End Stage Renal Disease
- What is being tested?
- Desflurane and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Jan 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- healthy kidney donors and their recipients of renal transplantation.
Who cannot join
- a donor that has any medical or surgical history,
- a recipient that is scheduled to have any other surgery with renal transplantation surgery.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance hospital, Yonsei University College of Medicine
Seoul, 120-752
About this study
Official title: The Comparison of Preconditioning Effect of Desflurane and Antiapoptotic Effect of Propofol in Patients With Kidney Transplantation
Ischemia/reperfusion (IR) injury is the major cause of early renal dysfunction and acute renal failure of the transplanted kidney after renal transplantation. In 1986, Murry et al. described the phenomenon "ischemic preconditioning". Also, it was reported that a few non-ischemic stimuli could provide cellular tolerance against major ischemia through a mechanism similar to ischemic preconditioning. In an animal study, 1 minimal alveolar concentration of volatile anesthetics - a clinically relevant concentration - was reported to have a protective effect against ischemia/reperfusion injury, the effect being variable between types of anesthetics. Also, there were somm reports that intravenous anesthetics such as propofol could reduce IR injury by decreasing oxidative stress and apoptosis.
By reducing the ischemia/reperfusion injury of the grafted kidney, the morbidity and mortality related to renal transplantation can be reduced as well. The objective of this study is to find out whether, according to the type of anesthetics (Desflurane vs. Propofol), there is a difference in the protective effect against ischemia/reperfusion injury of the grafted kidney in patients receiving renal transplantation.
- Conditions
- Healthy, End Stage Renal Disease
- Being tested
- Desflurane, Propofol
- Keywords
- Healthy Kidney Donors and Their Recipients with End Stage Renal Disease
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
In Desflurane group, donors and their recipients will be anesthetized with desflurane and remifentanil. In contrast, in Propofol group, donors will be anesthetized with Propofol and remifentanil and recipients will be anesthetized with desflurane and remifentanil.
PropofolDrug
In Desflurane group, donors and their recipients will be anesthetized with desflurane and remifentanil. In contrast, in Propofol group, donors will be anesthetized with Propofol and remifentanil and recipients will be anesthetized with desflurane and remifentanil.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Experimental | Not described Receives: Drug: Propofol |
| Desflurane group | Active comparator | Not described Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
BUN(Blood Urea Nitrogen)
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
Measured: 1 hour after surgery
Cr density
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
Measured: 1 hour after surgery
estimated GFR(Glomerular Filtration Ratio)
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
Measured: 1 hour after surgery
urine output to check the the degree of protection for renal function
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bon Nyeo Koo, MD, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132157
- Sponsor's protocol ID
- 4-2009-0598
- Status last verified
- Mar 2014
- First submitted
- 24 May 2010
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Preconditioning Effect of Desflurane and Antiapoptotic Effect of Propofol in Patients With Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01132157
- Acronym / sponsor ID
- 4-2009-0598
- Conditions
- Healthy, End Stage Renal Disease
- Keywords
- Healthy Kidney Donors and Their Recipients with End Stage Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 May 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.
Ischemia/reperfusion (IR) injury is the major cause of early renal dysfunction and acute renal failure of the transplanted kidney after renal transplantation. In 1986, Murry et al. described the phenomenon "ischemic preconditioning". Also, it was reported that a few non-ischemic stimuli could provide cellular tolerance against major ischemia through a mechanism similar to ischemic preconditioning. In an animal study, 1 minimal alveolar concentration of volatile anesthetics - a clinically relevant concentration - was reported to have a protective effect against ischemia/reperfusion injury, the effect being variable between types of anesthetics. Also, there were somm reports that intravenous anesthetics such as propofol could reduce IR injury by decreasing oxidative stress and apoptosis.
By reducing the ischemia/reperfusion injury of the grafted kidney, the morbidity and mortality related to renal transplantation can be reduced as well. The objective of this study is to find out whether, according to the type of anesthetics (Desflurane vs. Propofol), there is a difference in the protective effect against ischemia/reperfusion injury of the grafted kidney in patients receiving renal transplantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Experimental | Drug: Propofol |
| Desflurane group | Active comparator | Drug: Desflurane |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy kidney donors and their recipients of renal transplantation.
Key exclusion criteria (2 listed)
- a donor that has any medical or surgical history,
- a recipient that is scheduled to have any other surgery with renal transplantation surgery.
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 |
|---|---|---|
| DesfluraneIn Desflurane group, donors and their recipients will be anesthetized with desflurane and remifentanil. In contrast, in Propofol group, donors will be anesthetized with Propofol and remifentanil and recipients will be anesthetized with desflurane and remifentanil. | Drug | Desflurane group |
| PropofolIn Desflurane group, donors and their recipients will be anesthetized with desflurane and remifentanil. In contrast, in Propofol group, donors will be anesthetized with Propofol and remifentanil and recipients will be anesthetized with desflurane and remifentanil. | Drug | Propofol group |
Primary outcome
BUN(Blood Urea Nitrogen)
Time frame: 1 hour after surgery
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
Cr density
Time frame: 1 hour after surgery
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
estimated GFR(Glomerular Filtration Ratio)
Time frame: 1 hour after surgery
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
urine output to check the the degree of protection for renal function
Time frame: 1 hour after surgery
The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.
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 5 Mar 2014.
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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.
Bon Nyeo Koo, MD, Ph.D principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desflurane and Propofol in people with Healthy and End Stage Renal Disease, run by Yonsei University at 1 site in South Korea.
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 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 5 Mar 2014. 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 South Korea. 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?
BUN(Blood Urea Nitrogen) (time frame: 1 hour after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2014.