Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery

Not Applicable

Completed

• Conditions: Heart Valve Diseases; Coronary Artery Disease
• Interventions: Device: CytoSorb device

• Registration Number: NCT02297334
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-21
• Primary Completion: 2015-10
• Status Verified: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With CytoSorb device	CytoSorb device	Patients randomised to this arm are treated with the CytoSorb device during bypass.

Primary Outcome Measures

Name	Time	Method
Change of levels of cytokines during procedure compared to baseline	1) 5 minutes before bypass 2) 2 hours after begin of bypass, 3) at the end of bypass, approximately 3 hours after begin of bypass, 4) 6 hours after bypass 5) 24 hours after bypass	parameters to be measured are: interleukin (IL) 1, interleukin 6, interleukin 8, interleukin 10, tumor necrosis factor-alpha

Secondary Outcome Measures

Name	Time	Method
Change of hemodynamic parameters during procedure compared to baseline	1) 5 kinutes before bypass 2) 2 hours after begin of bypass, 3) at the end of bypass, approximately 3 hours after begin of bypass, 4) 6 hours after bypass 5) 24 hours after bypass	Hemodynamic and respiratory parameters such as mean arterial pressure, heart rate and peripheral oxygen saturation are recorded. In addition thermodilution parameters (stroke volume variability, global end diastole volume, extravascular lung water index, cardiac index, systemic vascular resistance) are measured. Volume and catecholamine therapies are managed by an algorithm based on thermodilution parameters.
Thromboelastometry	at the end of bypass, approximately 3 hours after begin of surgery	At the end of extracorporeal circulation a rotation thromboelastometry analysis is performed and the clotting time (CT), the clot formation time (CFT), the maximum clot firmness (MCF) in In- and Ex-Tem and the MCF in Fib-Tem are measured. Based on an institutional algorithm the coagulation therapy is performed according to the results of the thromboelastometry.
Change of cognitive and emotional state in comparison to condition before surgery	1)one day before surgery 2) 24 hours after bypass	To evaluate, if the use of the cytokine-filter has any influence on cognitive function or the emotional state, the patients perform the mini-mental state examination and answer questions of the Geriatric Depression Scale questionaire. Results before and 24 hours after end of bypass are recorded.

Trial Locations

Locations (1)

Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg; 🇩🇪 Hamburg, Germany