Effect of Cytokine Removal in Cardiopulmonary Bypass Patients Using the Cytosorb ™ Filter
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Elective Cardiac Surgical Interventions
- Sponsor
- Medical University of Vienna
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- IL-6
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in systemic inflammation and the main producers of pro- and antiinflammatory cytokines. Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6 and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory response induces post surgical monocyte immunosuppression which is indicated by an impaired production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral circulation with increased lactate levels, pronounced fluid accumulation, increased need of vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to decrease the inflammatory process have the potential to improve the perioperative course.
Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels for the first 36 hours after surgery and induces a decreased inflammatory response for up to 3 days post surgery.
Detailed Description
Patients, who have an elective cardiac surgical intervention with an expected CBP duration \>120 minutes (e.g.: valve surgery, coronary artery bypass graft (CABG), combined procedures) will be enrolled to the study after given informed consent. Patients, who decline will be asked to collect their secondary outcome data to create a "real - life" group and increase the number of patients in the control group. In this "real - life" group no additional blood samples will be taken.
Investigators
Dr. Martin Bernardi
Doctor
Medical University of Vienna
Eligibility Criteria
Inclusion Criteria
- •elective cardiac surgical intervention with an expected CBP duration \>120 minutes
Exclusion Criteria
- •Emergency procedures
- •Heart transplantation
- •Elective left ventricular assist device (LVAD) implantation
- •Pulmonary thromendarterectomy
- •Declined informed consent
- •Serum creatinine \> 2mg/dl
- •Body mass index \< 18
- •Age \< 18 years
- •Pregnant woman
- •Receiving chemotherapy or diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
Outcomes
Primary Outcomes
IL-6
Time Frame: 1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours