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

NCT ID: NCT01469676

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

In the Control group, a standard arterial line filter was inserted on CPB circuit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Filtering Group

In the Filtering group, a leukocyte filter was inserted in the arterial line circuit.

Group Type EXPERIMENTAL

Filtering group LG-6, Pall Biomedical Products

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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LeukoGard-6 Leukocyte depletion Leukoreduction

Eligibility Criteria

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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
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InCor Heart Institute

OTHER

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Maria José Carvalho Carmona

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria José C Carmona, phd

Role: PRINCIPAL_INVESTIGATOR

U Sao Paulo

Other Identifiers

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Leukocyte Filtration

Identifier Type: -

Identifier Source: org_study_id