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Clinical Trials/NCT01879176
NCT01879176
Completed
Phase 3

Effect of Cytokine Removal in Cardiopulmonary Bypass Patients Using the Cytosorb ™ Filter

Medical University of Vienna1 site in 1 country46 target enrollmentAugust 2013

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Elective Cardiac Surgical Interventions
Sponsor
Medical University of Vienna
Enrollment
46
Locations
1
Primary Endpoint
IL-6
Status
Completed
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
May 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Martin Bernardi

Doctor

Medical University of Vienna

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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