Removal of Cytokine on Cardiopulmonary Bypass With CytoSorb® Compared to on- and Off-pump Myocardial Revascularization
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Disease
- Sponsor
- University Hospital of Cologne
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Evolution of the inflammatory response
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Dr. Antje-Christin Deppe
MD, Resident Cardiac Surgery
University Hospital of Cologne
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Evolution of the inflammatory response
Time Frame: Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day
Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP
Secondary Outcomes
- kidney injury(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Length of catecholamine therapy(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Length of ICU and hospital stay(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Length of ventilation(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- MACCE (mortality; myocardial infarction; cerebrovascular accident)(participants will be followed for the duration of hospital stay, an expected average of 10 days)