Clinical Impact of Cytokine in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-07-31

Brief Summary

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Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can cause a systemic inflammatory response syndrome (SIRS) which is associated with increased morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a potential benefit for cardiac surgery patients.

The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the investigators conduct this prospective, observational pilot study to determine the clinical impact of the use of a cytokine adsorbing circuit during CBP.

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Detailed Description

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Patients, who have an elective myocardial revascularization and give there written consent will be enrolled to the study. Demographic, intraoperative, and postoperative data will be collected prospectively. Furthermore, blood samples (1. before induction of anaesthesia 2. at the end of CPB 3. 6 hours after surgery 4. 24 hours after surgery 5. 3-5 days after surgery) will be analyzed.

Conditions

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Coronary Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CPB + Cytosorb

On pump myocardial revascularization with the use of the cytokine adsorbing circuit (Cytosorb)

No interventions assigned to this group

CPB / Control

Controll group; on pump myocardial revascularization

No interventions assigned to this group

OPCAB / Control

Controll Group; off-pump myocardial revascularization

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* • Elective myocardial revascularization

Exclusion Criteria

* Emergency procedures
* Declined informed consent
* Body mass index \< 18
* Age \< 18 years
* Pregnant women
* Receiving chemotherapy
* Diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
* Receiving antileukocyte drugs
* Receiving TNF-α Blockers
* Receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen)
* CRP \> 5 mg/dl

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No