Clinical trial NCT02213939: Clinical Impact of Cytokine in Cardiac Surgery
Official title: Removal of Cytokine on Cardiopulmonary Bypass With CytoSorb® Compared to on- and Off-pump Myocardial Revascularization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Keywords: Myocardial revascularization
Cytosorb
Inflammatory response
Cardiopulmonary bypass
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving surgical myocardila revascularization

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of the inflammatory response
timeFrame: Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day
Secondary outcomes:
measure: Length of ICU and hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Length of ventilation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Length of catecholamine therapy
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: kidney injury
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: MACCE (mortality; myocardial infarction; cerebrovascular accident)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne; Department of Cardiothoracic Surgery
Study officials:
affiliation: University Hospital of Cologne; Department of Cardiothoracic Surgery;
name: Antje C Deppe, MD
role: PRINCIPAL_INVESTIGATOR
References: