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

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

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136979


Locations
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Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
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Principal Investigator: Seong-Hyop Kim, M.D, Ph.D Konkuk University Medical Center

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Responsible Party: Seong-Hyop Kim, Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT02136979     History of Changes
Other Study ID Numbers: KUH1160064
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Aortic Diseases
Propofol
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Vascular Diseases
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation