Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Conditions

Heart Valve Diseases

Coronary Artery Disease

Treatments

Device: CytoSorb device

Study type

Interventional

Funder types

Other

Identifiers

NCT02297334

ANA-UKE-PV 4420

Details and patient eligibility

About

The aim of this study is to prove that using a CytoSorb(TM) filter in the cardiopulmonary circuit attenuates the inflammatory response to extracorporeal circulation in patients undergoing cardiac surgery. The hypothesis is that removing cytokines from patients' blood by the CytoSorb device significantly improves circulation and outcome in patients undergoing on-pump cardiac surgery.

Full description

Cardiac surgery with cardiopulmonary bypass (CPB) induces an inflammatory response due to contact of patients' blood with foreign surfaces like tubes or the oxygenator, ischemic-reperfusion injury and surgical trauma. Inflammation is modulated by cytokines, especially, interleukins. The extent of cytokine release is further related to the duration of bypass and the amount of operating field suction. This results in a systemic inflammatory response syndrome (SIRS) with the risk of multiple organ dysfunction (MOD). Also in patients treated with extracorporeal membrane oxygenation (ECMO) an activation of the inflammation system is seen and accompanied with an increase of cytokine levels. The cytokine concentration correlates with the severity of the immune reaction and can be a predictor of the outcome of the patient. As severe SIRS and MOD significantly increase mortality, the attenuation of the inflammatory response is supposed to reduce morbidity and mortality after cardiac surgery.

For adult cardiac surgery and patients who are treated with an extracorporal assist device, a tool for cytokine elimination and attenuation of the inflammatory response seems to be beneficial.

In our study we are going to investigate if the use of the CytoSorb device can improve the outcome of patients undergoing elective coronar artery bypass and heart valve surgery.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

undergoing elective coronar bypass AND heart valve surgery
expected duration of bypass more than 120 min

Exclusion criteria

age under 18 years of age
pregnancy
medication that interacts with the immune system (e.g. steroids, immune suppressors)
patients with diagnosed immunodeficiency (e.g. HIV/AIDS)
heparin induced thrombocytopenia type II
patients that decline participation