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Biomarkers in Patients Undergoing Mechanical Ventilation

Observational Study in Patients Admitted in the Intensive Care Unit.Tracheal Bacterial Load Surveillance in Patients Undergoing Mechanical Ventilation - Assessment of Biomarkers in the Distinction Between Colonization and Infection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02078999
Acronym
VAP
Enrollment
211
Registered
2014-03-05
Start date
2008-09-30
Completion date
2015-09-30
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Keywords

Mechanical ventilation, procalcitonin, c-reactive protein

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

Detailed description

The investigators hypotized that: 1. 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. 2. 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. 3. 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). 4. 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). 5. 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).

Interventions

None listed

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
CollaboratorOTHER
Hospital Clinic of Barcelona
CollaboratorOTHER
Centro Hospitalar Lisboa Ocidental
CollaboratorOTHER_GOV
Hospital Universitario La Fe
CollaboratorOTHER
Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients admitted in the ICU, with an expected length of mechanical ventilation \> 3 days. * Not receiving antibiotics for \>24 hrs before ICU admission- An expected length of mechanical ventilation \> 3 days

Exclusion criteria

* Patients \<18 yrs old * Pregnancy and lactation * Fulminant hepatic failure * Pancreatitis * Patients with the diagnosis of disseminated cancer, expected to die or undergo withdrawal of treatment within 72 hours after enrolment.

Design outcomes

Primary

MeasureTime frameDescription
Procalcitonine (PCT) levels evolutionUp to 21 daysProcalcitonin (PCT) levels assessed daily up to 21 days

Secondary

MeasureTime frameDescription
C-Reactive Protein (CRP)Up to 21 daysTo 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 daysMeasurement of biomarkers namely, copeptin, adrenomedulin, atrial natriuretic peptide, Interleukine 6, Interleukine 1 and hydrogen peroxide

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026