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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

Tracking Information
First Submitted Date  ICMJE May 7, 2014
First Posted Date  ICMJE May 13, 2014
Last Update Posted Date January 18, 2018
Actual Study Start Date  ICMJE May 21, 2014
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2014)
CD39 and CD73 level [ Time Frame: from preoperative status to 72 hrs after CPB weaning status ]
Change History Complete list of historical versions of study NCT02136979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2014)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery
Official Title  ICMJE Effect of Propofol and Sevoflurane on Serum CD39 and CD73 Level After Open Heart Surgery With Cardiopulmonary Bypass
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Valvular Heart Disease
  • Aortic Disease
Intervention  ICMJE
  • Drug: Propofol
    group of patients with propofol-based anesthesia
    Other Name: Propofol group
  • Drug: Sevoflurane
    group of patients with sevoflurane-based anesthesia
    Other Name: Sevoflurane group
Study Arms  ICMJE
  • Active Comparator: Propofol group
    patients with propofol-based anesthesia
    Intervention: Drug: Propofol
  • Active Comparator: Sevoflurane group
    patients with sevoflurane-based anesthesia
    Intervention: Drug: Sevoflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2018)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2014)
1
Actual Study Completion Date  ICMJE August 10, 2017
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02136979
Other Study ID Numbers  ICMJE KUH1160064
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seong-Hyop Kim, Konkuk University Medical Center
Study Sponsor  ICMJE Konkuk University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seong-Hyop Kim, M.D, Ph.D Konkuk University Medical Center
PRS Account Konkuk University Medical Center
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP