NCT02297334

Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery

Reduction of Inflammation Reaction to Extracorporeal Circulation in Cardiac Surgery by Interleukin Dialysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Coronary Artery Disease
• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	CytoSorb device	In 20 patients the CytoSorb device will be installed into the extra corporeal circuit. A blood flow of 400ml/min is provided by an roller pump of the heart lung machine in a parallel stream to the main circulation.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-10-01
• Completion: 2017-08-01
• First posted: 2014-11-21
• Last updated: 2017-08-29

Locations

1 site across 1 country: Germany