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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02078999
Other study ID # Ventilator-adquired Pneumonia
Secondary ID VAP2008
Status Completed
Phase N/A
First received August 3, 2012
Last updated April 3, 2017
Start date September 2008
Est. completion date September 2015

Study information

Verified date April 2017
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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).


Recruitment information / eligibility

Status Completed
Enrollment 211
Est. completion date September 2015
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
Spain Hospital Parc Taulí Sabadell Barcelona

Sponsors (5)

Lead Sponsor Collaborator
Corporacion Parc Tauli Centro Hospitalar Lisboa Ocidental, Hospital Clinic of Barcelona, Hospital Universitari Vall d'Hebron Research Institute, Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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/s4 — View Citation

Póvoa P, Martin-Loeches I, Ramirez P, Bos LD, Esperatti M, Silvestre J, Gili G, Goma G, Berlanga E, Espasa M, Gonçalves E, Torres A, Artigas A. Biomarker kinetics in the prediction of VAP diagnosis: results from the BioVAP study. Ann Intensive Care. 2016 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Procalcitonine (PCT) levels evolution Procalcitonin (PCT) levels assessed daily up to 21 days Up to 21 days
Secondary C-Reactive Protein (CRP) To evaluate the value of serum C-Reactive Protein (CRP) concentrations in the distinction between colonization and pulmonary infection Up to 21 days
Secondary Biomarkers at day of Ventilator-Adquired Pneumonia (VAP) Measurement of biomarkers namely, copeptin, adrenomedulin, atrial natriuretic peptide, Interleukine 6, Interleukine 1 and hydrogen peroxide Up to 21 days
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