Continued Ventilation During Cardiopulmonary Bypass

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Non-ventilated Group; Other: Lung Ventilation

• Registration Number: NCT01627756
• Lead Sponsor: Medical University of Vienna

Brief Summary

Cardiopulmonary bypass (CPB) is well known to induce a strong anti-inflammatory response. The investigators examined whether continued mechanical ventilation during CPB alters systemic immune activation.

Detailed Description

Cardiopulmonary bypass is well known to induce a strong anti-inflammatory response. Studies had been shown that the contact of blood components with artificial surfaces, the surgical trauma, endotoxemia and a reperfusion injury are in part responsible for the seen immunological affect after surgery. The purpose of this study is to test the effect of continued mechanical ventilation during surgery on a blood marker called soluble ST2 in patients sera. Soluble ST2 acts as a decoy receptor of IL-33 and has anti-inflammatory effects. Elevated soluble ST2 concentrations are reported in patients with acute myocardial infarction, sepsis, congestive heart failure and elevates soluble ST2 levels are associated with adverse outcome.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Written informed consent
• age > 40 and < 80

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Exclusion Criteria

• treatment with steroids or immunomodulatory interventions during the past four weeks
• signs of an acute infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-ventilation Group	Non-ventilated Group	In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.
Ventilation Group	Lung Ventilation	Volume controlled ventilation was done during the whole surgery.

Primary Outcome Measures

Name	Time	Method
Alteration of soluble ST2 concentration in serum	Preoperative, postoperative, day 1, day 2, day 3, day 4, day 5 after surgery	Concentration of soluble ST2 will be assessed in the serum of patient´s preoperativem, postoperative and the following five consecutive days after surgery.

Trial Locations

Locations (1)

Medical University of Debrecen; 🇭🇺 Debrecen, Hungary