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

Not Applicable

Completed

• Conditions: Systemic Inflammatory Response Syndrome (SIRS); Leukocyte Disorders; Complications Due to Coronary Artery Bypass Graft
• Interventions: Device: Filtering group LG-6, Pall Biomedical Products

• Registration Number: NCT01469676
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2010-02
• Study Completion: 2010-10
• Study First Submitted: 2011-06-22
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-09
• Last Update Submitted: 2011-11-09
• Study First Posted: 2011-11-10
• Last Update Posted: 2011-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Filtering Group	Filtering group LG-6, Pall Biomedical Products	In the Filtering group, a leukocyte filter was inserted in the arterial line circuit.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.	24 hours	The secondary outcome was the evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.