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

University of Sao Paulo

Status: Completed

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

Treatments: Device: Filtering group LG-6, Pall Biomedical Products

Study type: Interventional

Funder types: Other

Identifiers

NCT01469676

Leukocyte Filtration

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Control group

No Intervention group

Description:

In the Control group, a standard arterial line filter was inserted on CPB circuit.

Filtering Group

Experimental group

Description:

In the Filtering group, a leukocyte filter was inserted in the arterial line circuit.

Treatment:

Device: Filtering group LG-6, Pall Biomedical Products