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

Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01469676
Acronym
PulmFunction
Enrollment
22
Registered
2011-11-10
Start date
2007-02-28
Completion date
2010-10-31
Last updated
2011-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Coronary Artery Bypass Surgery, Cardiopulmonary Bypass, Leukocyte Reduction Filtrations, Pulmonary Function, Systemic Inflammatory Response

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.

Interventions

DEVICEFiltering 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.

Sponsors

InCor Heart Institute
CollaboratorOTHER
Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.24 hoursThe primary outcome was the evaluation of the effects of leukocyte filtration on lung function in patients undergoing coronary surgery.

Secondary

MeasureTime frameDescription
Evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.24 hoursThe secondary outcome was the evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026