Cytokine Removal in Cardiopulmonary Bypass Patients

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.

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Key information

Conditions

Elective Cardiac Surgical Interventions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CytoSorb

Device

Other names: Polymer Based Adsorption Systems, ISO 13485:2003

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

CytoSorbents, Inc

Registry information

Official study title

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

Acronym: CytoSorb

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jun 17, 2013
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.