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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Filtering group LG-6, Pall Biomedical Products
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Systemic Inflammatory Response Syndrome (SIRS) focused on measuring Coronary Artery Bypass Surgery, Cardiopulmonary Bypass, Leukocyte Reduction Filtrations, Pulmonary Function, Systemic Inflammatory Response

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Filtering Group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 22, 2011
    Last Updated
    November 9, 2011
    Sponsor
    University of Sao Paulo
    Collaborators
    InCor Heart Institute, Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01469676
    Brief Title
    Effects of Cardiopulmonary Bypass (CPB)-Leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function
    Acronym
    PulmFunction
    Official Title
    Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    October 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    InCor Heart Institute, Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    In the Control group, a standard arterial line filter was inserted on CPB circuit.
    Arm Title
    Filtering Group
    Arm Type
    Experimental
    Arm Description
    In the Filtering group, a leukocyte filter was inserted in the arterial line circuit.
    Intervention Type
    Device
    Intervention Name(s)
    Filtering group LG-6, Pall Biomedical Products
    Other Intervention Name(s)
    LeukoGard-6, Leukocyte depletion, Leukoreduction
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.
    Description
    The primary outcome was the evaluation of the effects of leukocyte filtration on lung function in patients undergoing coronary surgery.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.
    Description
    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

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria José C Carmona, phd
    Organizational Affiliation
    U Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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