Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297334
• Other study ID #: ANA-UKE-PV 4420
• Status: Completed
• Phase: N/A
• First received: October 8, 2014
• Last updated: August 28, 2017
• Start date: September 2013
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Valve Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amount of administered fluids	The amount of fluids administered during operation is recorded.	at the end of surgery, approximately 3 hours after begin of surgery
Other	Amount of administered catecholamines.	The amount of catecholamines administered during operation is recorded.	at the end of surgery, approximately 3 hours after begin of surgery
Other	Amount of administered catecholamines	The amount of catecholamines administered during operation is recorded.	after discharge from ICU, approximately 24 hours after surgery
Other	Change of a set of general laboratory parameters during procedure	In laboratory tests we measure the whole blood count (red blood cells, white blood cells, thrombocytes), C-reactive protein, liver enzymes (GOT, GPT), kidney parameters (creatinine, glomerular filtration rate) and electrolytes (sodium, potassium, calcium) are measured.	1) 5 minutes before bypass 2) 2 hours after begin of bypass, 3) at the end of bypass, approximately 3 hours after begin of surgery 4) 6 hours after bypass 5) 24 hours after bypass
Other	Intensive care durations	After discharge from ICU the duration of stay and postoperative ventilation is recorded.	after discharge from ICU, approximately 24 hours after admission
Other	complication and adverse events	Any complications or adverse events, like death, bleeding, rethoracotomy or malignant arrhythmias are recorded.	24 hours after admission to ICU
Primary	Change of levels of cytokines during procedure compared to baseline	parameters to be measured are: interleukin (IL) 1, interleukin 6, interleukin 8, interleukin 10, tumor necrosis factor-alpha	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
Secondary	Change of hemodynamic parameters during procedure compared to baseline	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.	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
Secondary	Thromboelastometry	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.	at the end of bypass, approximately 3 hours after begin of surgery
Secondary	Change of cognitive and emotional state in comparison to condition before surgery	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.	1)one day before surgery 2) 24 hours after bypass