Effects of Cardiopulmonary Bypass (CPB)-Leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function (PulmFunction)
|ClinicalTrials.gov Identifier: NCT01469676|
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : November 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Systemic Inflammatory Response Syndrome (SIRS) Leukocyte Disorders Complications Due to Coronary Artery Bypass Graft||Device: Filtering group LG-6, Pall Biomedical Products||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||October 2010|
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.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469676
|Principal Investigator:||Maria José C Carmona, phd||U Sao Paulo|