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Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT02297334
First received: October 8, 2014
Last updated: November 25, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Coronary Artery Disease
Heart Valve Diseases
Device: CytoSorb device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduction of Inflammation Reaction to Extracorporeal Circulation in Cardiac Surgery by Interleukin Dialysis

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Change of levels of cytokines during procedure compared to baseline [ Time Frame: 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:
  • Change of hemodynamic parameters during procedure compared to baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Other Outcome Measures:
  • Amount of administered fluids [ Time Frame: at the end of surgery, approximately 3 hours after begin of surgery ]
    The amount of fluids administered during operation is recorded.

  • Amount of administered catecholamines. [ Time Frame: at the end of surgery, approximately 3 hours after begin of surgery ]
    The amount of catecholamines administered during operation is recorded.

  • Amount of administered catecholamines [ Time Frame: after discharge from ICU, approximately 24 hours after surgery ]
    The amount of catecholamines administered during operation is recorded.

  • Change of a set of general laboratory parameters during procedure [ Time Frame: 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 ]
    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.

  • Intensive care durations [ Time Frame: after discharge from ICU, approximately 24 hours after admission ]
    After discharge from ICU the duration of stay and postoperative ventilation is recorded.

  • complication and adverse events [ Time Frame: 24 hours after admission to ICU ]
    Any complications or adverse events, like death, bleeding, rethoracotomy or malignant arrhythmias are recorded.


Enrollment: 40
Study Start Date: September 2013
Estimated Study Completion Date: February 2017
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: With CytoSorb device
Patients randomised to this arm are treated with the CytoSorb device during bypass.
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.
Other Name: polymer beads adsorbent
No Intervention: Withouot device
Patients randomised to this arm are treated without the CytoSorb device during bypass.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02297334

Locations
Germany
Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Study Director: Jens C. Kubitz, MD PhD Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
Study Chair: Daniel A. Reuter, MD PhD Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
Principal Investigator: Alexander März, MD Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
Principal Investigator: Ingo Garau, MD Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg
  More Information

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02297334     History of Changes
Other Study ID Numbers: ANA-UKE-PV 4420
Study First Received: October 8, 2014
Last Updated: November 25, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
CytoSorb(TM)
cytokines
inflammation
cardiac surgery
extracorporeal bypass

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 25, 2017