Continued Ventilation During Cardiopulmonary Bypass

Study Overview
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Brief Summary
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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
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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.

Official Title
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Continued Mechanical Ventilation During CABG Operation Attenuates Systemic Immune Modulation

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Lung Ventilation
* Other: Non-ventilated Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent age > 40 and < 80 Exclusion Criteria: treatment with steroids or immunomodulatory interventions during the past four weeks signs of an acute infection

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventilation Group<br>Volume controlled ventilation was done during the whole surgery. | Other: Lung Ventilation<br>* In the ventilated group, mechanical ventilation was done with the half of the initial tidal volume (i.e. 3-4 ml/kg, 250-300ml) during the aortic cross-clamp.<br>|
| Active Comparator: Non-ventilation Group<br>In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation. | Other: Non-ventilated Group<br>* . In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic Surgery, Endotoxins, Respiration, Artificial, Immune System