Clinical Impact of Cytokine in Cardiac Surgery

NCT02213939 | Unknown DMC

• 1 other identifier: Cytosorb2014
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can cause a systemic inflammatory response syndrome (SIRS) which is associated with increased morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a potential benefit for cardiac surgery patients. The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the investigators conduct this prospective, observational pilot study to determine the clinical impact of the use of a cytokine adsorbing circuit during CBP.

Conditions

Coronary Disease

Keywords

Myocardial revascularization; Cytosorb; Inflammatory response; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Evolution of the inflammatory response

  Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP

  Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day

Secondary Outcomes (5)

• Length of ICU and hospital stay

  participants will be followed for the duration of hospital stay, an expected average of 10 days

• Length of ventilation

  participants will be followed for the duration of hospital stay, an expected average of 10 days

• Length of catecholamine therapy

  participants will be followed for the duration of hospital stay, an expected average of 10 days

• kidney injury

  participants will be followed for the duration of hospital stay, an expected average of 10 days

• MACCE (mortality; myocardial infarction; cerebrovascular accident)

  participants will be followed for the duration of hospital stay, an expected average of 10 days

Study Arms (3)

CPB + Cytosorb

On pump myocardial revascularization with the use of the cytokine adsorbing circuit (Cytosorb)

CPB / Control

Controll group; on pump myocardial revascularization

OPCAB / Control

Controll Group; off-pump myocardial revascularization

Eligibility Criteria

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

Study Population

Patients receiving surgical myocardila revascularization

You may qualify if:

• Elective myocardial revascularization

You may not qualify if:

• Emergency procedures
• Declined informed consent
• Body mass index \< 18
• Age \< 18 years
• Pregnant women
• Receiving chemotherapy
• Diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
• Receiving antileukocyte drugs
• Receiving TNF-α Blockers
• Receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen)
• CRP \> 5 mg/dl

Sponsors & Collaborators

• University Hospital of Cologne: lead

Study Sites (1)

University Hospital of Cologne; Department of Cardiothoracic Surgery

Cologne, 50379, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Antje C Deppe, MD

  University Hospital of Cologne; Department of Cardiothoracic Surgery;

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident Cardiac Surgery

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 12, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

DE (1)