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

Pneumonia, Ventilator-Associated Clinical Trial

— DIPOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683122
• Other study ID #: P15-37816003/2015-NI
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: February 24, 2017
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Centre Chirurgical Marie Lannelongue
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated

Locations

Country	Name	City	State
France	Centre Chirurgical Marie Lannelongue	Le Plessis Robinson

Sponsors (1)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality	Mortality during ICU stay	28 days