NCT02683122

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

January 11, 2016

Last Update Submit

February 24, 2017

Conditions

Pneumonia, Ventilator-Associated

Keywords

Organ dysfunction scoresPneumonia, Ventilator-AssociatedIntensive care units

Outcome Measures

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

    the previous 12 hours up to performance of pulmonary bacteriological samples

Secondary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in Intensive care unit after cardiac and/or thoracic surgery with a clinical suspicion of HAP

You may qualify if:

  • 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).

You may not qualify if:

  • child,
  • pregnancy,
  • end of life.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Related Publications (2)

  • 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.

    PMID: 12682500BACKGROUND

  • 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.

    PMID: 16003060BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • TALNA KORTCHINSKY, MD

    Centre Chirurgical Marie Lannelongue

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

February 17, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 27, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)