Clinical Impact of Cytokine in Cardiac Surgery

Coronary Disease Clinical Trial

Official title:

Removal of Cytokine on Cardiopulmonary Bypass With CytoSorb® Compared to on- and Off-pump Myocardial Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02213939
• Other study ID #: Cytosorb2014
• Status: Recruiting
• Phase: N/A
• First received: August 4, 2014
• Last updated: July 11, 2017
• Start date: August 2014
• Est. completion date: July 2018

Study information

• Verified date: July 2017
• Source: University Hospital of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a Blockers

• Receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen)

• CRP > 5 mg/dl

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Locations

Country	Name	City	State
Germany	University Hospital of Cologne; Department of Cardiothoracic Surgery	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Length of ventilation	Length of ventilation (hours)	participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary	Length of catecholamine therapy	Length of catecholamine therapy	participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary	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
Secondary	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