The DIPOD Study (Diagnosis Improvement of Pneumonia by Organ Dysfunction)

Study Overview
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Brief Summary
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The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial pneumonia in intensive care is not yet defined.

Detailed Description
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New onset of pulmonary infiltrates, fever, and an increase in white blood cell (WBC) count accompanied by purulent tracheal secretions are clinically indicative of hospital-associated pneumonia (HAP). The low specificity and sensibility of diagnostic tests for HAP, however, tends to result in an extremely high incidence of missed diagnoses and may lay to high mortality. The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial pneumonia in intensive care is not yet defined, because early organ dysfunction may be the first symptoms noted by clinicians.

Official Title
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Improvement of Diagnosis of Hospital Acquired Pneumonia (HAP) Based on Early Organ Dysfunction

Conditions
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Pneumonia, Ventilator-Associated

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients after cardiac/thoracic surgery with suspicion of HAP defined by the presence of the following criteria: new onset of pulmonary infiltrates, fever >38,3°C, increase in white blood cell (WBC) count purulent tracheal secretions but also: increased use of catecholamine, need of volemic expansion, depletion inability, confusion, hepatic perturbation with increased gamma-glutamyl transpeptidase (GGT)>2N or alkaline phosphatase (ALP) >1.5 N, or bilirubin >1.5N, or aminotransferase (AST or ALT>2 N). Exclusion Criteria: child, pregnancy, end of life.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the ROC curve of the CPIS score | The CPIS score is based on six variables: Fever Leukocytosis Tracheal aspirates Oxygenation Radiographic infiltrates Cult of tracheal aspirates | the previous 12 hours up to performance of pulmonary bacteriological samples | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the ROC curve of increased use of catecholamine and their positive and negative predictive values | Sensibility (%) and specificity (%) increased use of catecholamine | the previous 12 hours up to performance of pulmonary bacteriological samples | 
| Area under the ROC curve of increased need a volemic expansion and their positive and negative predictive values | Sensibility (%) and specificity (%) increased need a volemic expansion | the previous 12 hours up to performance of pulmonary bacteriological samples | 
| Area under the ROC curve of depletion inability and their positive and negative predictive values | Sensibility (%) and specificity (%) of depletion inability | the previous 12 hours up to performance of pulmonary bacteriological samples | 
| Area under the ROC curve of confusion and their positive and negative predictive values | Sensibility (%) and specificity (%) of confusion | the previous 12 hours up to performance of pulmonary bacteriological samples | 
| Area under the ROC curve of hepatic perturbation and their positive and negative predictive values | Sensibility (%) and specificity (%) of hepatic perturbation defined by increased gamma-glutamyl transpeptidase (CGT) and or alkaline phosphatase >1,5 N and or bilirubin >1,5 N or aminotransferase (AST or ALT >2 N) | the previous 12 hours up to performance of pulmonary bacteriological samples | 
| Mortality | Mortality during ICU stay | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organ dysfunction scores, Pneumonia, Ventilator-Associated, Intensive care units