Elective Cardiac Surgical Interventions Clinical Trial
Official title:
EFFECT OF CYTOKINE REMOVAL IN CARDIOPULMONARY BYPASS PATIENTS USING THE CYTOSORB ™ FILTER
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment