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Completed

NCT Number: NCT02297334

Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Heart Valve Diseases Inflammation Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CytoSorb device

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 names: polymer beads adsorbent

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

  3. Amount of administered catecholamines

    Time frame: after discharge from ICU, approximately 24 hours after surgery

    The amount of catecholamines administered during operation is recorded.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Nov 21, 2014
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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