Clinical trial NCT02078999: Biomarkers in Patients Undergoing Mechanical Ventilation
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Associated Pneumonia
Keywords: Mechanical ventilation, procalcitonin, c-reactive protein
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Vall d'Hebron Research Institute
name: Hospital Clinic of Barcelona
name: Centro Hospitalar Lisboa Ocidental
name: Hospital Universitario La Fe
First posted: 2014-03-05
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted in the ICU

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Procalcitonine (PCT) levels evolution
timeFrame: Up to 21 days
Secondary outcomes:
measure: C-Reactive Protein (CRP)
timeFrame: Up to 21 days
measure: Biomarkers at day of Ventilator-Adquired Pneumonia (VAP)
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
Study officials:
affiliation: hospital vall hebron barcelona
name: torres antonio, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic i provincial de Barcelona
name: palomar mercedes, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro hospitalario de lisboa occidental
name: povoa pedro, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Povoa P, Martin-Loeches I, Ramirez P, Bos LD, Esperatti M, Silvestre J, Gili G, Goma G, Berlanga E, Espasa M, Goncalves E, Torres A, Artigas A. Biomarker kinetics in the prediction of VAP diagnosis: results from the BioVAP study. Ann Intensive Care. 2016 Dec;6(1):32. doi: 10.1186/s13613-016-0134-8. Epub 2016 Apr 14.
citation: Martin-Loeches I, Bos LD, Povoa P, Ramirez P, Schultz MJ, Torres A, Artigas A. Tumor necrosis factor receptor 1 (TNFRI) for ventilator-associated pneumonia diagnosis by cytokine multiplex analysis. Intensive Care Med Exp. 2015 Dec;3(1):26. doi: 10.1186/s40635-015-0062-1. Epub 2015 Sep 16.
citation: Povoa P, Martin-Loeches I, Ramirez P, Bos LD, Esperatti M, Silvestre J, Gili G, Goma G, Berlanga E, Espasa M, Goncalves E, Torres A, Artigas A. Biomarkers kinetics in the assessment of ventilator-associated pneumonia response to antibiotics - results from the BioVAP study. J Crit Care. 2017 Oct;41:91-97. doi: 10.1016/j.jcrc.2017.05.007. Epub 2017 May 8.