Cytokine Removal in Cardiopulmonary Bypass Patients

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.

Conditions

• Elective Cardiac Surgical Interventions

Interventions

DEVICE

CytoSorb

Sponsors & Collaborators

• CytoSorbents, Inc

  collaborator INDUSTRY

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Michael Hiesmayr, MD · Medical University of Vienna

• Martin H Bernardi, MD · Medical University of Vienna

• Harald Rinösl, MD · Medical University of Vienna

• Friedrich Hoffelner · General Hospital of Vienna

• Andreas Spittler, MD · Medical University of Vienna

• Dominik Wiedemann, MD · Medical University of Vienna

• Philipp Opfermann, MD · Medical University of Vienna

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2015-05-31

Completion

2015-05-31

Countries

• Austria

Study Locations