Biomarkers in Patients Undergoing Mechanical Ventilation (VAP)

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

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

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia

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).

• Study Type: Observational
• Enrollment (Actual): 211

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted in the ICU

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procalcitonine (PCT) levels evolution	Procalcitonin (PCT) levels assessed daily up to 21 days	Up to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Hospital Universitari Vall d'Hebron Research Institute; Hospital Clinic of Barcelona; Hospital Universitario La Fe; Centro Hospitalar Lisboa Ocidental
• 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Mechanical ventilation, procalcitonin, c-reactive protein
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: Ventilator-adquired Pneumonia; VAP2008 (Other Identifier: Parc Tauli IRB)