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

Systemic Inflammatory Response Syndrome (SIRS) Clinical Trial

— PulmFunction  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469676
• Other study ID #: Leukocyte Filtration
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: November 9, 2011
• Start date: February 2007
• Est. completion date: October 2010

Study information

• Verified date: November 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo, InCor Heart Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours	Yes
Secondary	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.	24 hours	Yes