Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the inflammatory response | Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP | Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU and hospital stay | 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 | Length of ventilation (hours) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients receiving surgical myocardila revascularization
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antje C Deppe, MD | University Hospital of Cologne; Department of Cardiothoracic Surgery; | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Cologne; Department of Cardiothoracic Surgery | Recruiting | Cologne | 50379 | Germany |
Not provided
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
whole blood, serum
| participants will be followed for the duration of hospital stay, an expected average of 10 days |
| Length of catecholamine therapy | Length of catecholamine therapy | participants will be followed for the duration of hospital stay, an expected average of 10 days |
| kidney injury | 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. | participants will be followed for the duration of hospital stay, an expected average of 10 days |
| MACCE (mortality; myocardial infarction; cerebrovascular accident) | 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 | participants will be followed for the duration of hospital stay, an expected average of 10 days |