Clinical Trial: Effect of Cardiopulmonary Bypass on Serum CD39 and CD73 Level

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Effect of Cardiopulmonary Bypass on Serum CD39 and CD73 Level

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. In recent previous studies, CD39 and CD73 was known to have important role in cancer patients for inducing immunosuppressive reaction and consequently induce cancer cell proliferation. However, the immunosuppressive effect of CD39 and CD73 during CPB time was not evaluated in previous studies.

The authors hypothesized that CD39 and CD73 would have important role in CPB induced immunosuppression. Therefore, the present study determined the effect of CD39 and CD73 during CPB.

Detailed Summary:

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 6ml of urine sample was obtained for total 8 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 and urine sample, authors examined as follows

1. Flow cytometry for Th 17 and Th 1 cell.
2. Immunocytochemistry for CD39, CD73.
3. Assay
   Sponsor: Konkuk University Medical Center
   

   Current Primary Outcome: percent change from baseline in CD39 and CD73 level after CPB [ Time Frame: from preoperative status up to 48 hrs after CPB weaning status ]
   
   

   Original Primary Outcome: CD39 and CD73 level [ Time Frame: from preoperative status to 72 hrs after CPB weaning status ]
   
   

   Current Secondary Outcome: percent change from baseline in IL 1,4,6,8,10, TNF-α and other result of laboratory tests after CPB [ Time Frame: from preoperative status up to 48 hrs after CPB weaning status ]

   result of other laboratory tests includes CK-MB, TnI, BGA, OT/PT, BUN/Cr, CBC with diff. count, ESR, CRP
   
   
   

   Original Secondary Outcome: IL 1,4,6,8,10, TNF-α, result of other laboratory tests [ Time Frame: from preoperative status to 72 hrs after CPB weaning status ]

   result of other laboratory tests includes CK-MB, TnI, BGA, OT/PT, BUN/Cr, CBC with diff. count, ESR, CRP
   
   
   Information By: Konkuk University Medical Center
   

   Dates:
   Date Received: May 7, 2014
   Date Started: March 2014
   Date Completion: March 2017
   Last Updated: December 9, 2015
   Last Verified: December 2015