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

November 9, 2011 updated by: Maria José Carvalho Carmona, University of Sao Paulo

Effects of 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
In the Control group, a standard arterial line filter was inserted on CPB circuit.
EXPERIMENTAL: Filtering Group
In the Filtering group, a leukocyte filter was inserted in the arterial line circuit.
Device: 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.
Other Names:
  • LeukoGard-6
  • Leukocyte depletion
  • Leukoreduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

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

Investigators

  • Principal Investigator: Maria José C Carmona, phd, U Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

November 9, 2011

First Posted (ESTIMATE)

November 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leukocyte Filtration

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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