Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery

NCT ID: NCT02297334

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-08-31

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.

Conditions

Coronary Artery Disease; Heart Valve Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

With CytoSorb device

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

Group Type: ACTIVE_COMPARATOR

CytoSorb device

Intervention Type: 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.

Withouot device

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

polymer beads adsorbent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens C. Kubitz, MD PhD

Role: STUDY_DIRECTOR

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

Daniel A. Reuter, MD PhD

Role: STUDY_CHAIR

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

Alexander März, MD

Role: PRINCIPAL_INVESTIGATOR

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

Ingo Garau, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hamburg, , Germany

Countries

Germany

Other Identifiers

ANA-UKE-PV 4420

Identifier Type: -

Identifier Source: org_study_id