Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery

NCT ID: NCT02136979

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-21
• Study Completion Date: 2017-08-10

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.

Conditions

Valvular Heart Disease; Aortic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Propofol group

patients with propofol-based anesthesia

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

group of patients with propofol-based anesthesia

Sevoflurane group

patients with sevoflurane-based anesthesia

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

group of patients with sevoflurane-based anesthesia

Interventions

Propofol

group of patients with propofol-based anesthesia

Intervention Type: DRUG

Sevoflurane

group of patients with sevoflurane-based anesthesia

Intervention Type: DRUG

Other Intervention Names

Propofol group; Sevoflurane group

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konkuk University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seong-Hyop Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seong-Hyop Kim, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

Konkuk University Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KUH1160064

Identifier Type: -

Identifier Source: org_study_id