Valvular Heart DiseasePhase 4NCT02136979
Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery
A Phase 4 study testing Propofol and Sevoflurane in people with Valvular Heart Disease and Aortic Disease, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during cardiac surgery, and induce immunosuppression. Propofol and volatile anesthetics were related to immune reaction. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Valvular Heart Disease, Aortic Disease
- What is being tested?
- Propofol and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2014to 10 Aug 2017
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to undergo elective cardiac surgery
- signed written informed consent agreements
Who cannot join
- Emergency operation that could not obtain pre-CPB1 sample
- Patients who have infectious factor before operation
- Patients who have immunosuppressive agent for underlying disease before operation
- Patients who have history of cancer previously
- Patients who are younger than 19 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Propofol and Sevoflurane on Serum CD39 and CD73 Level After Open Heart Surgery With Cardiopulmonary Bypass
CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during cardiac surgery, and induce immunosuppression. Propofol and volatile anesthetics were related to immune reaction. However, the effect of propofol and sevoflurane on the change of CD39 and CD73 after CPB was not evaluated in previous studies.
The authors hypothesized that the expression of CD39 and CD73 would differ between propofol- and volatile anaesthetic-based anaesthesia in patients undergoing CPB. Therefore, the present study determined the effect of propofol and sevoflurane on CD39 and CD73 during and after CPB.
Read the detailed description
After obtaining permission of the Institutional Review Board of Konkuk University Medical Center, Seoul, South Korea , patients scheduled to undergo elective cardiac surgery under cardiopulmonary bypass (CPB) after signed written informed consent agreements and prospectively participate in the present study.
All patients got a cardiac surgery under moderate hypothermic cardiopulmonary bypass (CPB) by one cardiac surgeon. Also, 6ml of blood and sample was obtained for total 5 times in consecutive order.
- Before operation (pre-CPB1)
- 15 minute after successful CPB weaning (post-CPB1)
- 3 hrs after CPB weaning (post-CPB2)
- 24 hrs after CPB weaning (post-CPB3)
- 48 hrs after CPB weaning (post-CPB4)
The following intraoperative exclusion criteria are applied:
- Emergency operation that could not obtain pre-CPB1 sample
- Patients who have infectious factor before operation
- Patients who have immunosuppressive agent for underlying disease before operation
- Patients who have history of cancer previously
- Patients who are younger than 19 years old
Using blood sample, authors examined as follows
- Flow cytometry for Th 17 and Th 1 cell.
- Immunocytochemistry for CD39, CD73.
- Assay for IL 1,6,10,17,IFN-γ, and TNF-α
- patient vital sign during operation
- other laboratory tests
Statistical analyses are conducted using SPSS 20.0 (SPSS Inc., Chicago, IL, USA). CD39 and CD73 are analysed used a Repeated Measures Analysis of Variance and their pairwise multiple comparisons are performed via the tukey method. The comparisons of the other continuous variables are performed by paired t or Wilcoxon Signed Rank tests. Data are expressed as mean ± SD (95% confidence interval. CI) or median (25%-75%), and number of the patients. A p value less than 0.05 is considered statistically significant.
- Conditions
- Valvular Heart Disease, Aortic Disease
- Being tested
- Propofol, Sevoflurane
- Medical subject headings
- Heart Valve Diseases, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Propofol group
group of patients with propofol-based anesthesia
SevofluraneDrug
Also called Sevoflurane group
group of patients with sevoflurane-based anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | patients with propofol-based anesthesia Receives: Drug: Propofol |
| Sevoflurane group | Active comparator | patients with sevoflurane-based anesthesia Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of CD39 and CD73 between propofol and sevoflurane group after CPB
The difference of CD39 and CD73 level between propofol and sevoflurane group
Measured: from preoperative status up to 48 hrs after CPB weaning status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study start21 May 2014
- Primary completion31 Dec 2016
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Hyop Kim, Konkuk University Medical Center
- Investigators
- Seong-Hyop Kim, M.D, Ph.D, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136979
- Sponsor's protocol ID
- KUH1160064
- Status last verified
- Jan 2018
- First submitted
- 7 May 2014
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol and Sevoflurane on Serum CD39 and CD73 Level After Open Heart Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02136979
- Acronym / sponsor ID
- KUH1160064
- Conditions
- Valvular Heart Disease, Aortic Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 21 May 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 13 May 2014 (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.
CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during cardiac surgery, and induce immunosuppression. Propofol and volatile anesthetics were related to immune reaction. However, the effect of propofol and sevoflurane on the change of CD39 and CD73 after CPB was not evaluated in previous studies.
The authors hypothesized that the expression of CD39 and CD73 would differ between propofol- and volatile anaesthetic-based anaesthesia in patients undergoing CPB. Therefore, the present study determined the effect of propofol and sevoflurane on CD39 and CD73 during and after CPB.
Detailed description
After obtaining permission of the Institutional Review Board of Konkuk University Medical Center, Seoul, South Korea , patients scheduled to undergo elective cardiac surgery under cardiopulmonary bypass (CPB) after signed written informed consent agreements and prospectively participate in the present study.
All patients got a cardiac surgery under moderate hypothermic cardiopulmonary bypass (CPB) by one cardiac surgeon. Also, 6ml of blood and sample was obtained for total 5 times in consecutive order.
- Before operation (pre-CPB1)
- 15 minute after successful CPB weaning (post-CPB1)
- 3 hrs after CPB weaning (post-CPB2)
- 24 hrs after CPB weaning (post-CPB3)
- 48 hrs after CPB weaning (post-CPB4)
The following intraoperative exclusion criteria are applied:
- Emergency operation that could not obtain pre-CPB1 sample
- Patients who have infectious factor before operation
- Patients who have immunosuppressive agent for underlying disease before operation
- Patients who have history of cancer previously
- Patients who are younger than 19 years old
Using blood sample, authors examined as follows
- Flow cytometry for Th 17 and Th 1 cell.
- Immunocytochemistry for CD39, CD73.
- Assay for IL 1,6,10,17,IFN-γ, and TNF-α
- patient vital sign during operation
- other laboratory tests
Statistical analyses are conducted using SPSS 20.0 (SPSS Inc., Chicago, IL, USA). CD39 and CD73 are analysed used a Repeated Measures Analysis of Variance and their pairwise multiple comparisons are performed via the tukey method. The comparisons of the other continuous variables are performed by paired t or Wilcoxon Signed Rank tests. Data are expressed as mean ± SD (95% confidence interval. CI) or median (25%-75%), and number of the patients. A p value less than 0.05 is considered statistically significant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Active comparator | Drug: Propofolpatients with propofol-based anesthesia |
| Sevoflurane group | Active comparator | Drug: Sevofluranepatients with sevoflurane-based anesthesia |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled to undergo elective cardiac surgery
- signed written informed consent agreements
Key exclusion criteria (5 listed)
- Emergency operation that could not obtain pre-CPB1 sample
- Patients who have infectious factor before operation
- Patients who have immunosuppressive agent for underlying disease before operation
- Patients who have history of cancer previously
- Patients who are younger than 19 years old
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 |
|---|---|---|
| PropofolAlso: Propofol groupgroup of patients with propofol-based anesthesia | Drug | Propofol group |
| SevofluraneAlso: Sevoflurane groupgroup of patients with sevoflurane-based anesthesia | Drug | Sevoflurane group |
Primary outcome
The level of CD39 and CD73 between propofol and sevoflurane group after CPB
Time frame: from preoperative status up to 48 hrs after CPB weaning status
The difference of CD39 and CD73 level between propofol and sevoflurane group
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 Jan 2018.
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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.
Seong-Hyop Kim, M.D, Ph.D principal investigator
Konkuk University Medical Center
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 Propofol and Sevoflurane in people with Valvular Heart Disease and Aortic Disease, run by Konkuk University Medical Center 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 2 inclusion and 5 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 Jan 2018. 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?
The level of CD39 and CD73 between propofol and sevoflurane group after CPB (time frame: from preoperative status up to 48 hrs after CPB weaning status). 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 18 Jan 2018.