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

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ClinicalTrials.gov Identifier: NCT02683122
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

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

Condition or disease
Pneumonia, Ventilator-Associated

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.


Study Type : Observational
Actual Enrollment : 298 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improvement of Diagnosis of Hospital Acquired Pneumonia (HAP) Based on Early Organ Dysfunction
Study Start Date : January 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. Area under the ROC curve of the CPIS score [ Time Frame: the previous 12 hours up to performance of pulmonary bacteriological samples ]

    The CPIS score is based on six variables:

    • Fever
    • Leukocytosis
    • Tracheal aspirates
    • Oxygenation
    • Radiographic infiltrates
    • Cult of tracheal aspirates


Secondary Outcome Measures :
  1. Area under the ROC curve of increased use of catecholamine and their positive and negative predictive values [ Time Frame: the previous 12 hours up to performance of pulmonary bacteriological samples ]
    Sensibility (%) and specificity (%) increased use of catecholamine

  2. Area under the ROC curve of increased need a volemic expansion and their positive and negative predictive values [ Time Frame: the previous 12 hours up to performance of pulmonary bacteriological samples ]
    Sensibility (%) and specificity (%) increased need a volemic expansion

  3. Area under the ROC curve of depletion inability and their positive and negative predictive values [ Time Frame: the previous 12 hours up to performance of pulmonary bacteriological samples ]
    Sensibility (%) and specificity (%) of depletion inability

  4. Area under the ROC curve of confusion and their positive and negative predictive values [ Time Frame: the previous 12 hours up to performance of pulmonary bacteriological samples ]
    Sensibility (%) and specificity (%) of confusion

  5. Area under the ROC curve of hepatic perturbation and their positive and negative predictive values [ Time Frame: the previous 12 hours up to performance of pulmonary bacteriological samples ]
    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)

  6. Mortality [ Time Frame: 28 days ]
    Mortality during ICU stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in Intensive care unit after cardiac and/or thoracic surgery with a clinical suspicion of HAP
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683122


Locations
France
Centre Chirurgical Marie Lannelongue
Le Plessis Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Investigators
Principal Investigator: TALNA KORTCHINSKY, MD Centre Chirurgical Marie Lannelongue

Publications:
Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT02683122     History of Changes
Other Study ID Numbers: P15-37816003/2015-NI
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Chirurgical Marie Lannelongue:
Organ dysfunction scores
Pneumonia, Ventilator-Associated
Intensive care units

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury