Clinical trial NCT01469676: Effects of Cardiopulmonary Bypass (CPB)-Leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function
Official title: Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Inflammatory Response Syndrome (SIRS)
Leukocyte Disorders
Complications Due to Coronary Artery Bypass Graft
Keywords: Coronary Artery Bypass Surgery
Cardiopulmonary Bypass
Leukocyte Reduction Filtrations
Pulmonary Function
Systemic Inflammatory Response
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-11-10
Enrollment: 22
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.
timeFrame: 24 hours
Secondary outcomes:
measure: Evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: U Sao Paulo
name: Maria José C Carmona, phd
role: PRINCIPAL_INVESTIGATOR
References: