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

• ClinicalTrials.gov Identifier: NCT02136979
• Recruitment Status: Completed
• First Posted: May 13, 2014
• Last Update Posted: January 18, 2018
• Sponsor: Konkuk University Medical Center
• Information provided by (Responsible Party): Seong-Hyop Kim, Konkuk University Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Valvular Heart Disease; Aortic Disease	Drug: Propofol; Drug: Sevoflurane	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Propofol and Sevoflurane on Serum CD39 and CD73 Level After Open Heart Surgery With Cardiopulmonary Bypass
• Actual Study Start Date: May 21, 2014
• Actual Primary Completion Date: December 31, 2016
• Actual Study Completion Date: August 10, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Propofol group; patients with propofol-based anesthesia	Drug: Propofol; group of patients with propofol-based anesthesia; Other Name: Propofol group
Active Comparator: Sevoflurane group; patients with sevoflurane-based anesthesia	Drug: Sevoflurane; group of patients with sevoflurane-based anesthesia; Other Name: Sevoflurane group

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

Konkuk University Medical Center

Seoul, Korea, Republic of, 143-729

Sponsors and Collaborators

Konkuk University Medical Center

Investigators

• Principal Investigator: Seong-Hyop Kim, M.D, Ph.D; Konkuk University Medical Center

More Information

• Responsible Party: Seong-Hyop Kim, Professor, Konkuk University Medical Center
• ClinicalTrials.gov Identifier: NCT02136979
• Other Study ID Numbers: KUH1160064
• First Posted: May 13, 2014
• Last Update Posted: January 18, 2018
• Last Verified: January 2018

Additional relevant MeSH terms:

Heart Diseases; Heart Valve Diseases; Aortic Diseases; Cardiovascular Diseases; Vascular Diseases; Propofol; Sevoflurane; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation