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Systemic Inflammatory Response Evaluation With the Use of Inhaled Anesthetic Sevoflurane During CPB

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ClinicalTrials.gov Identifier: NCT02672345
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Thiago Augusto Azevedo Maranhão Cardoso, Instituto Dante Pazzanese de Cardiologia

Brief Summary:
Cardiac surgery has evolved considerably after the advent of cardiopulmonary bypass (CPB), a feature that allowed more precision and tranquility to the heart surgeon. But their influence on exacerbation of inflammatory response can unbalance the whole homeostasis so happens surgical trauma. The attenuation of the systemic inflammatory response in major surgeries like cardiac surgery for aortic aneurysm appears to represent an important advance in reducing morbidity and mortality of these patients. Some studies suggest that inhaled anesthetics such as sevoflurane appear to play an important role in this control, but the mechanism by which this happens is still unclear. This study has the primary purpose of analyzing from a clinical study sevoflurane inhalation anesthetic can change the inflammatory response induced by CPB, significantly reducing the release of inflammatory markers, especially elastase PMN.

Condition or disease Intervention/treatment
Inflammatory Response Drug: Sevoflurane

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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Systemic Inflammatory Response Evaluation With the Use of Inhaled Anesthetic Sevoflurane During CPB
Actual Study Start Date : August 2016
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Group/Cohort Intervention/treatment
Sevoflurane Group
Group of patients receiving sevorane during extracorporeal circulation period.
Drug: Sevoflurane
The Sevoflurane Group will receive between 0.7 and 1.5% of sevoflurane CAM only during CPB period. While Not Sevoflurane Group will receive only intravenous anesthetic agents.

Not Sevoflurane Group
Group of patients who did not receive the sevorane during extracorporeal circulation period.



Primary Outcome Measures :
  1. Reduction of systemic inflammatory response [ Time Frame: Through study completion, an average of 1 year ]
    Cytokines are assayed in both groups at 4 different times in order to check the impact of sevoflurane on the inflammatory response. The first one is the baseline of measurement with which the others are compared and all will be compared within and between groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Will be selected 100 patients who underwent cardiac surgery of coronary artery bypass graft electively in Dante Pazzanese Institute of Cardiology (IDPC).
Criteria

Inclusion Criteria:

  • Age over 18 years
  • Cardiac Surgery elective of coronary artery bypass graft with cardiopulmonary bypass (CPB)
  • The informed consent signature savvy

Exclusion Criteria:

  • Use of steroids or anti-inflammatory drugs routine
  • Presence of asthma, COPD, autoimmune diseases
  • Participation in other clinical studies
  • Presence of decompensated heart failures, liver or kidney
  • Combined elective surgery (ex .: aneurysm correction + CABG)
  • Acute myocardial infarction in the last 30 days
  • Unstable angina
  • And obesity (BMI> 50kg / m2)

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): NCT02672345


Locations
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Brazil
Thiago Augusto Azevedo Maranhão Cardoso
São Paulo, Brazil, 01423020
Sponsors and Collaborators
Instituto Dante Pazzanese de Cardiologia
Additional Information:

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Responsible Party: Thiago Augusto Azevedo Maranhão Cardoso, MD, Instituto Dante Pazzanese de Cardiologia
ClinicalTrials.gov Identifier: NCT02672345    
Other Study ID Numbers: 4617
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Keywords provided by Thiago Augusto Azevedo Maranhão Cardoso, Instituto Dante Pazzanese de Cardiologia:
Sevoflurane
MicroRNAs
Inflammatory Response
Cytokines
Anesthetics, Inhalation
Macrophage Inflammatory Proteins
Additional relevant MeSH terms:
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Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs