Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery
Primary Purpose
Valvular Heart Disease, Aortic Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
About this trial
This is an interventional basic science trial for Valvular Heart Disease
Eligibility Criteria
Inclusion Criteria:
- patients scheduled to undergo elective cardiac surgery
- signed written informed consent agreements
Exclusion Criteria:
- 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
Sites / Locations
- Konkuk University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Propofol group
Sevoflurane group
Arm Description
patients with propofol-based anesthesia
patients with sevoflurane-based anesthesia
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02136979
First Posted
May 7, 2014
Last Updated
January 16, 2018
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02136979
Brief Title
Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery
Official Title
Effect of Propofol and Sevoflurane on Serum CD39 and CD73 Level After Open Heart Surgery With Cardiopulmonary Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 21, 2014 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
August 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease, Aortic Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol group
Arm Type
Active Comparator
Arm Description
patients with propofol-based anesthesia
Arm Title
Sevoflurane group
Arm Type
Active Comparator
Arm Description
patients with sevoflurane-based anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Propofol group
Intervention Description
group of patients with propofol-based anesthesia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevoflurane group
Intervention Description
group of patients with sevoflurane-based anesthesia
Primary Outcome Measure Information:
Title
The level of CD39 and CD73 between propofol and sevoflurane group after CPB
Description
The difference of CD39 and CD73 level between propofol and sevoflurane group
Time Frame
from preoperative status up to 48 hrs after CPB weaning status
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients scheduled to undergo elective cardiac surgery
signed written informed consent agreements
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Hyop Kim, M.D, Ph.D
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
12. IPD Sharing Statement
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Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery
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