Clinical Impact of Cytokine in Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT02213939|
Recruitment Status : Unknown
Verified July 2017 by Dr. Antje-Christin Deppe, University Hospital of Cologne.
Recruitment status was: Recruiting
First Posted : August 12, 2014
Last Update Posted : July 12, 2017
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Removal of Cytokine on Cardiopulmonary Bypass With CytoSorb® Compared to on- and Off-pump Myocardial Revascularization|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||July 2018|
CPB + Cytosorb
On pump myocardial revascularization with the use of the cytokine adsorbing circuit (Cytosorb)
CPB / Control
Controll group; on pump myocardial revascularization
OPCAB / Control
Controll Group; off-pump myocardial revascularization
- 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
- Length of ICU and hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]Length of ICU and hospital stay
- Length of ventilation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]Length of ventilation (hours)
- Length of catecholamine therapy [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]Length of catecholamine therapy
- kidney injury [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]kidney injury defined as an increase in SCr by ≥1.0 mg/dl (≥26.5 μmol/l) after surgery ; or Increase in SCr to ≥1.5 times baseline, or Urine volume < 0.5 ml/kg/h for 6 hours.
- MACCE (mortality; myocardial infarction; cerebrovascular accident) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]Mortality measured as any kind of death and myocardial death Myocardial Infarction measured with ECG; CK-MB, cTnT Cerebrovascular accident verified with abnormal cerebral CT scan
Biospecimen Retention: Samples Without DNA
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): NCT02213939
|University Hospital of Cologne; Department of Cardiothoracic Surgery||Recruiting|
|Cologne, Germany, 50379|
|Contact: Antje C Deppe, MD 0049 221 478 32453 firstname.lastname@example.org|
|Contact: Yeong-Hoon Choi, MD 0049221 478 32452 email@example.com|
|Principal Investigator:||Antje C Deppe, MD||University Hospital of Cologne; Department of Cardiothoracic Surgery;|