VAP: Biomarkers in Patients Undergoing Mechanical Ventilation
Study Details
Study Description
Brief Summary
To evaluate in a cohort of patients on mechanical ventilation, for non-infectious reasons and for documented sepsis of pulmonary as well as non-pulmonary origin, the bacterial load, procalcitonine (PCT), C-Reactive Protein (CRP), temperature, White cell count (WCC), American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) consensus conference criteria, Sequential Organ Failure Assessment score (SOFA) and simplified Clinical Pulmonary Infection Score (CPIS) through the mechanical ventilation period
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The investigators hypotized that:
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In patients on mechanical ventilation for a non-infectious cause of respiratory failure, the tracheal bacterial load should be absent or below the cut-off values defined for infection, that is to say tracheal colonization.
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In patients without the diagnosis of Ventilator-Adquired Pneumonia (VAP) and not taking antibiotics till the weaning process, tracheal bacterial load should remain below the predefined cut-off values and the biomarkers (PCT and CRP) should be surrogate markers of this clinical course.
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In patients developing VAP, an increase in tracheal bacterial load should precede diagnosis with an associated rise in the biomarkers levels (PCT and CRP). Finally, after institution of antibiotic therapy, adequate therapy should be associated with a decrease tracheal bacterial load as well as of the biomarkers (PCT and CRP).
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In patients admitted with clinical suspicion of pneumonia, either community-acquired (CAP) or hospital-acquired (HAP), with microbiological documentation, after institution of antibiotic therapy, adequate therapy should be associated with a decrease tracheal bacterial load as well as the biomarkers (PCT and CRP).
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In patients admitted with clinical suspicion of a non-pulmonary infection (e.g. peritonitis and urosepsis) and on mechanical ventilation for an expected length longer than 3 days, either community or hospital-acquired, preferentially with microbiological documentation, after institution of antibiotic therapy, adequate therapy should be associated with a decrease of biomarkers (PCT and CRP).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Control Grup Daily clinical data collection Quantitative tracheal aspirates (QTA) every 3 days Deep freeze serum samples for posterior analysis every day (two aliquots). In patients with documented pneumonia daily collection of the following variables will continue: CRP, PCT, ABG, mechanical ventilation parameters, ACCP/SCCM consensus conference criteria, simplified CPIS, SOFA. |
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| Patients with pulmonary infection Daily clinical data collection Quantitative tracheal aspirates (QTA) every 3 days Deep freeze serum samples for posterior analysis every day (two aliquots). In patients with documented pneumonia daily collection of the following variables will continue: CRP, PCT, ABG, mechanical ventilation parameters, ACCP/SCCM consensus conference criteria, simplified CPIS, SOFA. |
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| Patients with extrapulmonary infection Daily clinical data collection Quantitative tracheal aspirates (QTA) every 3 days Deep freeze serum samples for posterior analysis every day (two aliquots). In patients with documented pneumonia daily collection of the following variables will continue: CRP, PCT, ABG, mechanical ventilation parameters, ACCP/SCCM consensus conference criteria, simplified CPIS, SOFA. |
Outcome Measures
Primary Outcome Measures
- Procalcitonine (PCT) levels evolution [Up to 21 days]
Procalcitonin (PCT) levels assessed daily up to 21 days
Secondary Outcome Measures
- C-Reactive Protein (CRP) [Up to 21 days]
To evaluate the value of serum C-Reactive Protein (CRP) concentrations in the distinction between colonization and pulmonary infection
- Biomarkers at day of Ventilator-Adquired Pneumonia (VAP) [Up to 21 days]
Measurement of biomarkers namely, copeptin, adrenomedulin, atrial natriuretic peptide, Interleukine 6, Interleukine 1 and hydrogen peroxide
Eligibility Criteria
Criteria
Inclusion criteria:
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Patients admitted in the ICU, with an expected length of mechanical ventilation > 3 days.
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Not receiving antibiotics for >24 hrs before ICU admission- An expected length of mechanical ventilation > 3 days
Exclusion Criteria:
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Patients <18 yrs old
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Pregnancy and lactation
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Fulminant hepatic failure
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Pancreatitis
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Patients with the diagnosis of disseminated cancer, expected to die or undergo withdrawal of treatment within 72 hours after enrolment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Parc Taulí | Sabadell | Barcelona | Spain | 08208 |
Sponsors and Collaborators
- Corporacion Parc Tauli
- Hospital Universitari Vall d'Hebron Research Institute
- Hospital Clinic of Barcelona
- Centro Hospitalar Lisboa Ocidental
- Hospital Universitario La Fe
Investigators
- Principal Investigator: torres antonio, doctor, hospital vall hebron barcelona
- Principal Investigator: palomar mercedes, doctor, Hospital Clinic i provincial de Barcelona
- Principal Investigator: povoa pedro, doctor, Centro hospitalario de lisboa occidental
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Ventilator-adquired Pneumonia
- VAP2008