Cytokine Removal in Cardiopulmonary Bypass Patients (CytoSorb)
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|ClinicalTrials.gov Identifier: NCT01879176|
Recruitment Status : Completed
First Posted : June 17, 2013
Results First Posted : January 10, 2017
Last Update Posted : February 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Elective Cardiac Surgical Interventions||Device: CytoSorb||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Cytokine Removal in Cardiopulmonary Bypass Patients Using the Cytosorb ™ Filter|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .
No Intervention: Control
No filter will be installed on the CPB machine.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879176
|Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna|
|Vienna, Austria, 1090|
|Study Director:||Michael Hiesmayr, MD||Medical University of Vienna|
|Principal Investigator:||Martin H Bernardi, MD||Medical University of Vienna|
|Study Chair:||Harald Rinösl, MD||Medical University of Vienna|
|Study Chair:||Friedrich Hoffelner||General Hospital of Vienna|
|Study Director:||Andreas Spittler, MD||Medical University of Vienna|
|Study Chair:||Dominik Wiedemann, MD||Medical University of Vienna|
|Study Chair:||Philipp Opfermann, MD||Medical University of Vienna|