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Cytokine Removal in Cardiopulmonary Bypass Patients (CytoSorb)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01879176
Recruitment Status : Completed
First Posted : June 17, 2013
Results First Posted : January 10, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
CytoSorbents, Inc
Information provided by (Responsible Party):
Dr. Martin Bernardi, Medical University of Vienna

Study Description
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Brief Summary:

Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in systemic inflammation and the main producers of pro- and antiinflammatory cytokines. Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6 and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory response induces post surgical monocyte immunosuppression which is indicated by an impaired production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral circulation with increased lactate levels, pronounced fluid accumulation, increased need of vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to decrease the inflammatory process have the potential to improve the perioperative course.

Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels for the first 36 hours after surgery and induces a decreased inflammatory response for up to 3 days post surgery.


Condition or disease Intervention/treatment Phase
Elective Cardiac Surgical Interventions Device: CytoSorb Phase 3

Detailed Description:

Patients, who have an elective cardiac surgical intervention with an expected CBP duration >120 minutes (e.g.: valve surgery, coronary artery bypass graft (CABG), combined procedures) will be enrolled to the study after given informed consent.

Patients, who decline will be asked to collect their secondary outcome data to create a "real - life" group and increase the number of patients in the control group. In this "real - life" group no additional blood samples will be taken.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Cytokine Removal in Cardiopulmonary Bypass Patients Using the Cytosorb ™ Filter
Study Start Date : August 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: CytoSorb
For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .
 Device: CytoSorb
Other Names:
  • Polymer Based Adsorption Systems
  • ISO 13485:2003
No Intervention: Control
No filter will be installed on the CPB machine.


Outcome Measures
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Primary Outcome Measures :
  1. IL-6 [ Time Frame: 1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective cardiac surgical intervention with an expected CBP duration >120 minutes

Exclusion Criteria:

  • Emergency procedures
  • Heart transplantation
  • Elective left ventricular assist device (LVAD) implantation
  • Pulmonary thromendarterectomy
  • Declined informed consent
  • Serum creatinine > 2mg/dl
  • Body mass index < 18
  • Age < 18 years
  • Pregnant woman
  • Receiving chemotherapy or diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
  • Receiving antileukocyte drugs
  • Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)
  • CRP > 2mg/dl
  • History of Stroke
  • Bilirubin >2mg/dl
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879176


Locations
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Austria
Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
CytoSorbents, Inc
Investigators
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Study Director: Michael Hiesmayr, MD Medical University of Vienna
Principal Investigator: Martin H Bernardi, MD Medical University of Vienna
Study Chair: Harald Rinösl, MD Medical University of Vienna
Study Chair: Friedrich Hoffelner General Hospital of Vienna
Study Director: Andreas Spittler, MD Medical University of Vienna
Study Chair: Dominik Wiedemann, MD Medical University of Vienna
Study Chair: Philipp Opfermann, MD Medical University of Vienna
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Martin Bernardi, Doctor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01879176    
Other Study ID Numbers: 1095/2013
First Posted: June 17, 2013    Key Record Dates
Results First Posted: January 10, 2017
Last Update Posted: February 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No