Inflammatory ResponseNCT02672345
Systemic Inflammatory Response Evaluation With the Use of Inhaled Anesthetic Sevoflurane During CPB
An observational study of Inflammatory Response, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- Sevoflurane
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Jun 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Will be selected 100 patients who underwent cardiac surgery of coronary artery bypass graft electively in Dante Pazzanese Institute of Cardiology (IDPC).
Who may be able to join
- Age over 18 years
- Cardiac Surgery elective of coronary artery bypass graft with cardiopulmonary bypass (CPB)
- The informed consent signature savvy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inflammatory Response
- Being tested
- Sevoflurane
- Keywords
- Sevoflurane, MicroRNAs, Inflammatory Response, Cytokines, Anesthetics, Inhalation, Macrophage Inflammatory Proteins
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Group | Group of patients receiving sevorane during extracorporeal circulation period. Receives: Drug: Sevoflurane | |
| Not Sevoflurane Group | Group of patients who did not receive the sevorane during extracorporeal circulation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of systemic inflammatory response
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thiago Augusto Azevedo Maranhão Cardoso, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672345
- Sponsor's protocol ID
- 4617
- Status last verified
- Jun 2020
- First submitted
- 28 Jan 2016
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cardoso TAAM, Kunst G, Neto CN, de Ribamar Costa Junior J, Silva CGS, Bastos GM, Borges JB, Hirata MH. Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):25. doi: 10.1186/s13063-020-04809-x.
PubMed 33407763
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammatory Response Evaluation With the Use of Inhaled Anesthetic Sevoflurane During CPB
- ClinicalTrials.gov ID
- NCT02672345
- Acronym / sponsor ID
- 4617
- Conditions
- Inflammatory Response
- Keywords
- Sevoflurane, MicroRNAs, Inflammatory Response, Cytokines, Anesthetics, Inhalation, Macrophage Inflammatory Proteins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Group | – | Drug: SevofluraneGroup of patients receiving sevorane during extracorporeal circulation period. |
| Not Sevoflurane Group | – | –Group of patients who did not receive the sevorane during extracorporeal circulation period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Will be selected 100 patients who underwent cardiac surgery of coronary artery bypass graft electively in Dante Pazzanese Institute of Cardiology (IDPC).
Key inclusion criteria (3 listed)
- Age over 18 years
- Cardiac Surgery elective of coronary artery bypass graft with cardiopulmonary bypass (CPB)
- The informed consent signature savvy
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneThe 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. | Drug | Sevoflurane Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Derived from this study: PubMed 33407763Cardoso TAAM, Kunst G, Neto CN, de Ribamar Costa Junior J, Silva CGS, Bastos GM, Borges JB, Hirata MH. Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):25. doi: 10.1186/s13063-020-04809-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Response, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of systemic inflammatory response (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02672345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.