Clinical Impact of Cytokine in Cardiac Surgery

University Hospital of Cologne

Status: Unknown

Conditions: Coronary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02213939

Cytosorb2014

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

CPB + Cytosorb

Description:

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

CPB / Control

Description:

Controll group; on pump myocardial revascularization

OPCAB / Control

Description:

Controll Group; off-pump myocardial revascularization