Systemic Inflammatory Response Syndrome (SIRS)PulmFunctionNCT01469676
Effects of Cardiopulmonary Bypass (CPB)-Leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function
A study testing Filtering group LG-6, Pall Biomedical Products in people with Systemic Inflammatory Response Syndrome (SIRS) and Leukocyte Disorders, run by University of Sao Paulo.
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 Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Systemic Inflammatory Response Syndrome (SIRS), Leukocyte Disorders, Complications Due to Coronary Artery Bypass Graft
- What is being tested?
- Filtering group LG-6, Pall Biomedical Products
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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
Read the 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.
- Conditions
- Systemic Inflammatory Response Syndrome (SIRS), Leukocyte Disorders, Complications Due to Coronary Artery Bypass Graft
- Being tested
- Filtering group LG-6, Pall Biomedical Products
- Keywords
- Coronary Artery Bypass Surgery, Cardiopulmonary Bypass, Leukocyte Reduction Filtrations, Pulmonary Function, Systemic Inflammatory Response
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Leukocyte Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filtering group LG-6, Pall Biomedical ProductsDevice
Also called LeukoGard-6, Leukocyte depletion, Leukoreduction
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Filtering group LG-6, Pall Biomedical Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startFeb 2007
- Primary completionFeb 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response Syndrome (SIRS)Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Maria José Carvalho Carmona, University of Sao Paulo
- Investigators
- Maria José C Carmona, phd, Principal investigator, U Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469676
- Sponsor's protocol ID
- Leukocyte Filtration
- Acronym
- PulmFunction
- Status last verified
- Nov 2011
- First submitted
- 22 Jun 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.
- ClinicalTrials.gov ID
- NCT01469676
- Acronym / sponsor ID
- PulmFunction / Leukocyte Filtration
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- InCor Heart Institute, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –In the Control group, a standard arterial line filter was inserted on CPB circuit. |
| Filtering Group | Experimental | Device: Filtering group LG-6, Pall Biomedical ProductsIn the Filtering group, a leukocyte filter was inserted in the arterial line circuit. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filtering group LG-6, Pall Biomedical ProductsAlso: LeukoGard-6, Leukocyte depletion, LeukoreductionIn 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. | Device | Filtering Group |
Primary outcome
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.
1 secondary outcome
Evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria José C Carmona, phd principal investigator
U Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Filtering group LG-6, Pall Biomedical Products in people with Systemic Inflammatory Response Syndrome (SIRS) and Leukocyte Disorders, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2011.