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

June 20, 2020 updated by: Thiago Augusto Azevedo Maranhão Cardoso, Instituto Dante Pazzanese de Cardiologia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01423020
        • Thiago Augusto Azevedo Maranhão Cardoso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Dante Pazzanese de Cardiologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 20, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4617

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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