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

Completed

• Conditions: Pneumonia, Ventilator-Associated

• Registration Number: NCT02683122
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-17
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the ROC curve of the CPIS score	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

Name	Time	Method
Area under the ROC curve of increased need a volemic expansion and their positive and negative predictive values	the previous 12 hours up to performance of pulmonary bacteriological samples	Sensibility (%) and specificity (%) increased need a volemic expansion
Area under the ROC curve of confusion and their positive and negative predictive values	the previous 12 hours up to performance of pulmonary bacteriological samples	Sensibility (%) and specificity (%) of confusion
Area under the ROC curve of depletion inability and their positive and negative predictive values	the previous 12 hours up to performance of pulmonary bacteriological samples	Sensibility (%) and specificity (%) of depletion inability
Area under the ROC curve of increased use of catecholamine and their positive and negative predictive values	the previous 12 hours up to performance of pulmonary bacteriological samples	Sensibility (%) and specificity (%) increased use of catecholamine
Area under the ROC curve of hepatic perturbation and their positive and negative predictive values	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)
Mortality	28 days	Mortality during ICU stay

Trial Locations

Locations (1)

Centre Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis Robinson, France