Clinical trial NCT02297334: Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery
Official title: Reduction of Inflammation Reaction to Extracorporeal Circulation in Cardiac Surgery by Interleukin Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Heart Valve Diseases
Keywords: CytoSorb(TM)
cytokines
inflammation
cardiac surgery
extracorporeal bypass
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of levels of cytokines during procedure compared to baseline
timeFrame: 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 outcomes:
measure: Change of hemodynamic parameters during procedure compared to baseline
timeFrame: 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
measure: Thromboelastometry
timeFrame: at the end of bypass, approximately 3 hours after begin of surgery
measure: Change of cognitive and emotional state in comparison to condition before surgery
timeFrame: 1)one day before surgery 2) 24 hours after bypass
Other outcomes:
measure: Amount of administered fluids
timeFrame: at the end of surgery, approximately 3 hours after begin of surgery
measure: Amount of administered catecholamines.
timeFrame: at the end of surgery, approximately 3 hours after begin of surgery
measure: Amount of administered catecholamines
timeFrame: after discharge from ICU, approximately 24 hours after surgery
measure: Change of a set of general laboratory parameters during procedure
timeFrame: 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
measure: Intensive care durations
timeFrame: after discharge from ICU, approximately 24 hours after admission
measure: complication and adverse events
timeFrame: 24 hours after admission to ICU
Locations:
city: Hamburg
country: Germany
facility: Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
Study officials:
affiliation: Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
name: Jens C. Kubitz, MD PhD
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
name: Daniel A. Reuter, MD PhD
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
name: Alexander März, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
name: Ingo Garau, MD
role: PRINCIPAL_INVESTIGATOR
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