Clinical Impact of Cytokine in Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Hospital of Cologne
Sponsor:
Information provided by (Responsible Party):
Dr. Antje-Christin Deppe, University Hospital of Cologne
ClinicalTrials.gov Identifier:
NCT02213939
First received: August 4, 2014
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Removal of Cytokine on Cardiopulmonary Bypass With CytoSorb® Compared to on- and Off-pump Myocardial Revascularization

Resource links provided by NLM:


Further study details as provided by University Hospital of Cologne:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP


Secondary Outcome Measures:
  • Length of ICU and hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Length of catecholamine therapy

  • kidney injury [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

whole blood, serum


Estimated Enrollment: 300
Study Start Date: August 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients receiving surgical myocardila revascularization

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02213939

Locations
Germany
University Hospital of Cologne; Department of Cardiothoracic Surgery Recruiting
Cologne, Germany, 50379
Contact: Antje C Deppe, MD    0049 221 478 32453    antje-christin.deppe@uk-koeln.de   
Contact: Yeong-Hoon Choi, MD    0049221 478 32452    yeong-hoon.choi@uk-koeln.de   
Sponsors and Collaborators
University Hospital of Cologne
Investigators
Principal Investigator: Antje C Deppe, MD University Hospital of Cologne; Department of Cardiothoracic Surgery;
  More Information

No publications provided

Responsible Party: Dr. Antje-Christin Deppe, MD, Resident Cardiac Surgery, University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT02213939     History of Changes
Other Study ID Numbers: Cytosorb2014
Study First Received: August 4, 2014
Last Updated: August 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital of Cologne:
Myocardial revascularization
Cytosorb
Inflammatory response
Cardiopulmonary bypass

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 16, 2014