An interventional study of Filtering group LG-6, Pall Biomedical Products in Systemic Inflammatory Response Syndrome (SIRS), Leukocyte Disorders and Complications Due to Coronary Artery Bypass Graft, sponsored by University of Sao Paulo. Completed. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2011-11-10.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Prevention
To test the hypothesis that leukocyte filtering during cardiopulmonary bypass (CPB) might reduce the inflammatory response and protect the lungs against the acute injury
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.
180 studies on the registry are indexed under Systemic Inflammatory Response Syndrome; 24 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 88 interventional studies indexed under Systemic Inflammatory Response Syndrome.
Browse Systemic Inflammatory Response Syndrome studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
In the Control group, a standard arterial line filter was inserted on CPB circuit.
In the Filtering group, a leukocyte filter was inserted in the arterial line circuit.
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.
Also known as: LeukoGard-6, Leukocyte depletion, Leukoreduction
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.
Time frame: 24 hours
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.
Time frame: 24 hours
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This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Leukocyte Disorders
University of Sao Paulo