Effects of Cardiopulmonary Bypass (CPB)-Leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function

Study Overview
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Brief Summary
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To test the hypothesis that leukocyte filtering during cardiopulmonary bypass (CPB) might reduce the inflammatory response and protect the lungs against the acute injury

Detailed Description
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BACKGROUND AND OBJECTIVES: The extension of the systemic inflammatory response observed after cardiopulmonary bypass (CPB) in cardiac surgery is associated to postoperative pulmonary dysfunction degree. The leukocyte depletion during CPB can modify that response. The aim of this study was to evaluate the effects of leukocyte filtering on the inflammatory response and lung function in patients undergoing coronary artery bypass grafting. METHODS: After approval by the institutional ethical committee, a prospective randomized study was performed to compare nine patients undergoing coronary artery bypass grafting (CABG) using leukocyte filtration in the arterial line (LG-6, Pall Biomedical Products) and eleven others submitted to standard CPB. Chest CT, oxygenation analysis and a complete leucocyte count were performed before surgery. After intravenous anesthesia induction, patients were mechanically ventilated with tidal volume of 8 mL.kg-1, with FiO2 0.6, and PEEP of 5 cm H2O, except during CPB. Haemodynamic data, PaO2/FiO2, shunt fraction, interleukins, elastase and myeloperoxidase were evaluated before and after CPB, at the end of surgery, 6, 12 and 24 hours after surgery. Chest CT was repeated on the first postoperative day. Data were analyzed using two-factor ANOVA for repeated measures.

Official Title
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Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.

Conditions
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Systemic Inflammatory Response Syndrome (SIRS), Leukocyte Disorders, Complications Due to Coronary Artery Bypass Graft

Intervention / Treatment
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* Device: Filtering group LG-6, Pall Biomedical Products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing coronary artery bypass grafting (CABG), having their physical state classified as PII and PIII, according to the American Society of Anesthesiologists (ASA). Surgical risk was stratified according to Parsonnet criteria, and only patients considered low to moderate risk were admitted. Exclusion Criteria: Subjects older than 70 years Body mass index (BMI) over 35 kg/m2 Congestive heart failure (CHF) greater than class III (NYHA) Left ventricle ejection fraction less than 40% Submitted to recent surgery creatinine ≥ 1.4 mg / dL or in use of oral anticoagulants were excluded

Ages Eligible for Study
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Maximum Age: 70 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>In the Control group, a standard arterial line filter was inserted on CPB circuit. | |
| Experimental: Filtering Group<br>In the Filtering group, a leukocyte filter was inserted in the arterial line circuit. | Device: Filtering group LG-6, Pall Biomedical Products<br>* In Filtering group, a Leukocyte filter (LG-6, Pall Biomedical Products) was placed on the CPB arterial line circuit, trying to filter the white blood cells.<br>* Other names: Leukoreduction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function. | The primary outcome was the evaluation of the effects of leukocyte filtration on lung function in patients undergoing coronary surgery. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery. | The secondary outcome was the evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Surgery, Cardiopulmonary Bypass, Leukocyte Reduction Filtrations, Pulmonary Function, Systemic Inflammatory Response