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 Title of Study: “Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Prevention
- Masking: Single (Participant)
- Study Primary Completion Date: February 2010
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.
- Device: Filtering group LG-6, Pall Biomedical Products
- 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.
Arms, Groups and Cohorts
- No Intervention: Control group
- In the Control group, a standard arterial line filter was inserted on CPB circuit.
- Experimental: Filtering Group
- In the Filtering group, a leukocyte filter was inserted in the arterial line circuit.
Clinical Trial Outcome Measures
- Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.
- Time Frame: 24 hours
- The primary outcome was the evaluation of the effects of leukocyte filtration on lung function in patients undergoing coronary surgery.
- Evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.
- Time Frame: 24 hours
- The secondary outcome was the evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Sao Paulo
- InCor Heart Institute
- Provider of Information About this Clinical Study
- Principal Investigator: Maria José Carvalho Carmona, Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function – University of Sao Paulo
- Overall Official(s)
- Maria José C Carmona, phd, Principal Investigator, U Sao Paulo
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