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

Valvular Heart Disease Clinical Trial

Official title:

Effect of Propofol and Sevoflurane on Serum CD39 and CD73 Level After Open Heart Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136979
• Other study ID #: KUH1160064
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2014
• Last updated: January 16, 2018
• Start date: May 21, 2014
• Est. completion date: August 10, 2017

Study information

• Verified date: January 2018
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 10, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Disease
• Aortic Diseases
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Drug:
• Propofol
group of patients with propofol-based anesthesia
• Sevoflurane
group of patients with sevoflurane-based anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from preoperative status up to 48 hrs after CPB weaning status