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CompletedNCT02683122DIPODUpdated Feb 27, 2017

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

An observational study in Pneumonia, Ventilator-Associated, sponsored by Centre Chirurgical Marie Lannelongue. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-27.

Sponsored by Centre Chirurgical Marie Lannelongue · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
298
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Pneumonia, Ventilator-Associated

Keywords

  • Organ dysfunction scores
  • Pneumonia, Ventilator-Associated
  • Intensive care units
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 298 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Centre Chirurgical Marie Lannelongue is the lead sponsor of 40 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

  • child,
  • pregnancy,
  • end of life.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
298 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

Secondary outcomes

  1. Area under the ROC curve of increased use of catecholamine and their positive and negative predictive values

    Sensibility (%) and specificity (%) increased use of catecholamine

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

  2. 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

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

  3. Area under the ROC curve of depletion inability and their positive and negative predictive values

    Sensibility (%) and specificity (%) of depletion inability

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

  4. Area under the ROC curve of confusion and their positive and negative predictive values

    Sensibility (%) and specificity (%) of confusion

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

  5. 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)

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

  6. Mortality

    Mortality during ICU stay

    Time frame: 28 days

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Study locations

1 site
  • Centre Chirurgical Marie Lannelongue
    Le Plessis Robinson, 92350, France
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References and documents

Publications

  • 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. PubMed 12682500 ↗
  • 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. PubMed 16003060 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02683122
Lead sponsor
Centre Chirurgical Marie Lannelongue
Responsible party
Sponsor
First posted
Feb 17, 2016
Start date
Jan 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Feb 27, 2017

Study contacts

TALNA KORTCHINSKY, MD
principal investigator · Centre Chirurgical Marie Lannelongue

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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