Clinical trial NCT02136979: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Valvular Heart Disease
Aortic Disease
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 2
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

1. Before operation (pre-CPB1)
2. 15 minute after successful CPB weaning (post-CPB1)
3. 3 hrs after CPB weaning (post-CPB2)
4. 24 hrs after CPB weaning (post-CPB3)
5. 48 hrs after CPB weaning (post-CPB4)

The following intraoperative exclusion criteria are applied:

1. Emergency operation that could not obtain pre-CPB1 sample
2. Patients who have infectious factor before operation
3. Patients who have immunosuppressive agent for underlying disease before operation
4. Patients who have history of cancer previously
5. Patients who are younger than 19 years old

Using blood sample, authors examined as follows

1. Flow cytometry for Th 17 and Th 1 cell.
2. Immunocytochemistry for CD39, CD73.
3. Assay for IL 1,6,10,17,IFN-γ, and TNF-α
4. patient vital sign during operation
5. 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.

Eligibility criteria: Inclusion Criteria:

1. patients scheduled to undergo elective cardiac surgery
2. signed written informed consent agreements

Exclusion Criteria:

1. Emergency operation that could not obtain pre-CPB1 sample
2. Patients who have infectious factor before operation
3. Patients who have immunosuppressive agent for underlying disease before operation
4. Patients who have history of cancer previously
5. Patients who are younger than 19 years old

Primary outcomes:
measure: The level of CD39 and CD73 between propofol and sevoflurane group after CPB
timeFrame: from preoperative status up to 48 hrs after CPB weaning status
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Seong-Hyop Kim, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: