Status:
COMPLETED
Cytokine Removal in Cardiopulmonary Bypass Patients
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
CytoSorbents, Inc
Conditions:
Elective Cardiac Surgical Interventions
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 enrolle...
Eligibility Criteria
Inclusion
- elective cardiac surgical intervention with an expected CBP duration \>120 minutes
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01879176
Start Date
August 1 2013
End Date
May 1 2015
Last Update
February 23 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna
Vienna, Vienna, Austria, 1090