Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery

NCT02297334 | Completed

• 1 other identifier: ANA-UKE-PV 4420
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Heart Valve Diseases

Keywords

CytoSorb(TM); cytokines; inflammation; cardiac surgery; extracorporeal bypass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Thromboelastometry

  at the end of bypass, approximately 3 hours after begin of surgery

• Change of cognitive and emotional state in comparison to condition before surgery

  1)one day before surgery 2) 24 hours after bypass

Other Outcomes (6)

• Amount of administered fluids

  at the end of surgery, approximately 3 hours after begin of surgery

• Amount of administered catecholamines.

  at the end of surgery, approximately 3 hours after begin of surgery

• Amount of administered catecholamines

  after discharge from ICU, approximately 24 hours after surgery

Study Arms (2)

With CytoSorb device

ACTIVE COMPARATOR

Patients randomised to this arm are treated with the CytoSorb device during bypass.

Device: CytoSorb device

Withouot device

NO INTERVENTION

Patients randomised to this arm are treated without the CytoSorb device during bypass.

Interventions

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.

Also known as: polymer beads adsorbent

With CytoSorb device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing elective coronar bypass AND heart valve surgery
• expected duration of bypass more than 120 min

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Jens C. Kubitz, MD PhD

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

  STUDY DIRECTOR

• Daniel A. Reuter, MD PhD

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

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: November 21, 2014
• Study Start: September 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: August 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

DE (1)