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

NCT01469676 | Completed

• 1 other identifier: Leukocyte Filtration
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.

  24 hours

Study Arms (2)

Control group

NO INTERVENTION

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

Filtering Group

EXPERIMENTAL

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

Device: Filtering group LG-6, Pall Biomedical Products

Interventions

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.

Also known as: LeukoGard-6, Leukocyte depletion, Leukoreduction

Filtering Group

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• InCor Heart Institute: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Leukocyte Disorders

Interventions

Leukocyte Reduction Procedures

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Maria José C Carmona, phd

  U Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: November 10, 2011
• Study Start: February 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 10, 2011

Record last verified: 2011-11