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Completed

NCT Number: NCT02078999

Biomarkers in Patients Undergoing Mechanical Ventilation

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

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Key information

Conditions

Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

About this study

The investigators hypotized that:

  • 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.
  • 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.
  • 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).
  • 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).
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Procalcitonine (PCT) levels evolution

    Time frame: Up to 21 days

    Procalcitonin (PCT) levels assessed daily up to 21 days

Secondary outcomes

  1. C-Reactive Protein (CRP)

    Time frame: Up to 21 days

    To evaluate the value of serum C-Reactive Protein (CRP) concentrations in the distinction between colonization and pulmonary infection

  2. Biomarkers at day of Ventilator-Adquired Pneumonia (VAP)

    Time frame: Up to 21 days

    Measurement of biomarkers namely, copeptin, adrenomedulin, atrial natriuretic peptide, Interleukine 6, Interleukine 1 and hydrogen peroxide

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Centro Hospitalar Lisboa Ocidental
  • Hospital Clinic of Barcelona
  • Hospital Universitari Vall d'Hebron Research Institute
  • Hospital Universitario La Fe

Registry information

Official study 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

Acronym: VAP

Important dates

Study start
2008
Primary completion
2010
Study completion
2015
First posted
Mar 5, 2014
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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