Coronary Disease
Conditions
Keywords
Myocardial revascularization, Cytosorb, Inflammatory response, Cardiopulmonary bypass
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University Hospital of Cologne
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Elective myocardial revascularization
Exclusion criteria
* Emergency procedures * Declined informed consent * Body mass index \< 18 * Age \< 18 years * Pregnant women * Receiving chemotherapy * Diagnosed with any disease state (e.g., AIDS) that has produced leukopenia * Receiving antileukocyte drugs * Receiving TNF-α Blockers * Receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen) * CRP \> 5 mg/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the inflammatory response | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU and hospital stay | 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 | participants will be followed for the duration of hospital stay, an expected average of 10 days | Length of ventilation (hours) |
| Length of catecholamine therapy | participants will be followed for the duration of hospital stay, an expected average of 10 days | Length of catecholamine therapy |
| kidney injury | 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) | 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 |
Countries
Germany
Outcome results
None listed