Clinical trial NCT02683122: The DIPOD Study (Diagnosis Improvement of Pneumonia by Organ Dysfunction)
Official title: Improvement of Diagnosis of Hospital Acquired Pneumonia (HAP) Based on Early Organ Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Ventilator-Associated
Keywords: Organ dysfunction scores
Pneumonia, Ventilator-Associated
Intensive care units
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Intensive care unit after cardiac and/or thoracic surgery with a clinical suspicion of HAP

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Area under the ROC curve of the CPIS score
timeFrame: the previous 12 hours up to performance of pulmonary bacteriological samples
Secondary outcomes:
measure: Area under the ROC curve of increased use of catecholamine and their positive and negative predictive values
timeFrame: the previous 12 hours up to performance of pulmonary bacteriological samples
measure: Area under the ROC curve of increased need a volemic expansion and their positive and negative predictive values
timeFrame: the previous 12 hours up to performance of pulmonary bacteriological samples
measure: Area under the ROC curve of depletion inability and their positive and negative predictive values
timeFrame: the previous 12 hours up to performance of pulmonary bacteriological samples
measure: Area under the ROC curve of confusion and their positive and negative predictive values
timeFrame: the previous 12 hours up to performance of pulmonary bacteriological samples
measure: Area under the ROC curve of hepatic perturbation and their positive and negative predictive values
timeFrame: the previous 12 hours up to performance of pulmonary bacteriological samples
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
Study officials:
affiliation: Centre Chirurgical Marie Lannelongue
name: TALNA KORTCHINSKY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.
citation: Calandra T, Cohen J; International Sepsis Forum Definition of Infection in the ICU Consensus Conference. The international sepsis forum consensus conference on definitions of infection in the intensive care unit. Crit Care Med. 2005 Jul;33(7):1538-48. doi: 10.1097/01.ccm.0000168253.91200.83.