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Completed

NCT Number: NCT00726167

Serum Procalcitonin Study in the Management of Ventilated Patients

The purpose of this study is to test a new method for diagnosing and monitoring Ventilator-Associated Pneumonia, which is a major killer among ICU patients. The method requires analysis of a small amount of the patient's blood for concentration of a hormone called Procalcitonin.

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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

University of Missouri

Columbia, Missouri, 65212, United States

About this study

Ventilator-associated pneumonia is a leading cause of mortality in critically ill patients. The purpose of this study is to evaluate the relationship between the onset/progress/resolution of pneumonia and the levels of Procalcitonin, a prohormone whose concentrations fluctuate in response to bacterial infection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Are willing to give or who's proxy is willing to consent to be a study subject
  • Are at least 18 years of age;
  • Who are mechanically ventilated surgical intensive care unit patients.

Exclusion criteria

  • Participation in any investigational device or drug trial within 30 days prior to enrollment.

Treatment and study plan

Procalcitonin Level

Device

Procalcitonin concentrations will be determined every day and will be compared with the clinical diagnosis based upon standard clinical practice. All subjects enrolled will be followed until the patient is either extubated or discharged from the SICU.

Other names: PCT

Primary outcomes

  1. Correlation of Procalcitonin concentration with the LungGuardian-derived Pneumonia Score in mechanically ventilated surgical intensive care unit patients. Using the data collected a positive and negative predictive value will be calculated.

    Time frame: Once daily

Secondary outcomes

  1. antibiotic status (appropriateness, effectiveness, discontinuation criteria)

    Time frame: Once daily

  2. intubation date

    Time frame: Once daily

  3. microbiology data

    Time frame: Once daily

  4. PCT levels

    Time frame: Once daily

  5. pneumonia-related symptoms (including tracheal secretion character, body temperature, oxygenation, and WBC counts)

    Time frame: Once daily

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Clinical Utility of Serum Procalcitonin in the Management of Ventilator-Associated Pneumonia

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jul 31, 2008
Registry last updated
Oct 5, 2016

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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