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Completed

NCT Number: NCT01469676

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

To test the hypothesis that leukocyte filtering during cardiopulmonary bypass (CPB) might reduce the inflammatory response and protect the lungs against the acute injury

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Key information

Conditions

Systemic Inflammatory Response Syndrome (SIRS) Complications Due to Coronary Artery Bypass Graft Hematologic Diseases Hemic and Lymphatic Diseases Inflammation Leukocyte Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filtering group LG-6, Pall Biomedical Products

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.

Other names: LeukoGard-6, Leukocyte depletion, Leukoreduction

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • InCor Heart Institute

Registry information

Official study title

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

Acronym: PulmFunction

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 10, 2011
Registry last updated
Nov 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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