Aortic Valve StenosisPhase 4NCT02019797
Desflurane-induced Myocardial Protection
A Phase 4 study testing Desflurane in people with Aortic Valve Stenosis, run by Nobuyuki Katori at 1 site in Japan.
Trial summary
This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2014to Dec 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass.
Who cannot join
- Patients younger than 20 years old.
- Recent myocardial infarction (within 1 year).
- Renal dysfunction (GFR less than 50ml/min).
- Known allergy to study drugs including propofol.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Keio University Hospital
Tokyo, 160-8582
Nobuyuki Katori, M.D., 81-3-3353-1211 ext. 61608, nbyk@a5.keio.jp
Hiroshi Morisaki, M.D., 81-3-3353-1211 ext. 61608, morisaki@z8.keio.jp
About this study
Official title: Desflurane-induced Myocardial Protection in Aortic Valve Surgery: A Pilot Study
This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery.
Read the detailed description
Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass are included in the study. Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a TIVA during the surgery. All patients receive a continuous infusion of remifentanil. Biomarker of myocardial damage troponin I is examined at 4 points; T1: after the induction of anesthesia, T2: arrival at ICU, T3: 12 hours after the ICU arrival, T4: 24 hours after the ICU arrival, T5: third post operative day (3POD).
- Conditions
- Aortic Valve Stenosis
- Being tested
- Desflurane
- Keywords
- aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called SUPRANE
Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and before cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a propofol during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Experimental | Desflurane inhalation at 1-2 MAC during surgery. Receives: Drug: Desflurane |
| Propofol | Active comparator | 5-8 mg/kg/hr infusion during surgery. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin I
Measured: up to 3 days
Secondary outcomes (2)
Length of ICU stay, Length of hospital stay
Measured: up to 2 months after the surgery
Acute myocardial infarction
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nobuyuki Katori
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor-investigator, Nobuyuki Katori, Keio University
- Investigators
- Makoto Suematsu, M.D., Ph.D, Study chair, Keio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019797
- Sponsor's protocol ID
- Desflurane
- Status last verified
- Dec 2013
- First submitted
- 18 Dec 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desflurane-induced Myocardial Protection in Aortic Valve Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT02019797
- Acronym / sponsor ID
- Desflurane
- Conditions
- Aortic Valve Stenosis
- Keywords
- aortic valve replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nobuyuki KatoriUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Dec 2013 (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.
This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery.
Detailed description
Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass are included in the study. Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a TIVA during the surgery. All patients receive a continuous infusion of remifentanil. Biomarker of myocardial damage troponin I is examined at 4 points; T1: after the induction of anesthesia, T2: arrival at ICU, T3: 12 hours after the ICU arrival, T4: 24 hours after the ICU arrival, T5: third post operative day (3POD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Experimental | Drug: DesfluraneDesflurane inhalation at 1-2 MAC during surgery. |
| Propofol | Active comparator | Drug: Desflurane5-8 mg/kg/hr infusion during surgery. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass.
Key exclusion criteria (4 listed)
- Patients younger than 20 years old.
- Recent myocardial infarction (within 1 year).
- Renal dysfunction (GFR less than 50ml/min).
- Known allergy to study drugs including propofol.
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 |
|---|---|---|
| DesfluraneAlso: SUPRANEPatients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and before cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a propofol during the surgery. | Drug | Desflurane, Propofol |
Primary outcome
Troponin I
Time frame: up to 3 days
2 secondary outcomes
Length of ICU stay, Length of hospital stay
Time frame: up to 2 months after the surgery
Acute myocardial infarction
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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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.
Makoto Suematsu, M.D., Ph.D study chair
Keio University
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 in people with Aortic Valve Stenosis, run by Nobuyuki Katori at 1 site in Japan.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Dec 2013. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nobuyuki Katori, M.D. (81-3-3353-1211 ext. 61608, nbyk@a5.keio.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin I (time frame: up to 3 days). 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 24 Dec 2013.