Biomarkers in Patients Undergoing Mechanical Ventilation

Ventilator Associated Pneumonia Clinical Trial

— VAP  

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

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
• 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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

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