Pneumonia, Ventilator-AssociatedDIPODNCT02683122
The DIPOD Study (Diagnosis Improvement of Pneumonia by Organ Dysfunction)
An observational study of Pneumonia, Ventilator-Associated, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial pneumonia in intensive care is not yet defined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- How many people
- 298 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in Intensive care unit after cardiac and/or thoracic surgery with a clinical suspicion of HAP
Who may be able to join
- 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:
Show all 11Show fewer
- 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).
Who cannot join
- child,
- pregnancy,
- end of life.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement of Diagnosis of Hospital Acquired Pneumonia (HAP) Based on Early Organ Dysfunction
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.
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Organ dysfunction scores, Pneumonia, Ventilator-Associated, Intensive care units
- Medical subject headings
- Pneumonia, Ventilator-Associated
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Sensibility (%) and specificity (%) increased use of catecholamine
Measured: 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
Sensibility (%) and specificity (%) increased need a volemic expansion
Measured: 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
Sensibility (%) and specificity (%) of depletion inability
Measured: 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
Sensibility (%) and specificity (%) of confusion
Measured: 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
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)
Measured: the previous 12 hours up to performance of pulmonary bacteriological samples
Mortality
Mortality during ICU stay
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TALNA KORTCHINSKY, MD, Principal investigator, Centre Chirurgical Marie Lannelongue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683122
- Sponsor's protocol ID
- P15-37816003/2015-NI
- Acronym
- DIPOD
- Status last verified
- Feb 2017
- First submitted
- 11 Jan 2016
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 12682500Calandra 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Diagnosis of Hospital Acquired Pneumonia (HAP) Based on Early Organ Dysfunction
- ClinicalTrials.gov ID
- NCT02683122
- Acronym / sponsor ID
- DIPOD / P15-37816003/2015-NI
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Organ dysfunction scores, Pneumonia, Ventilator-Associated, Intensive care units
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Intensive care unit after cardiac and/or thoracic surgery with a clinical suspicion of HAP
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- child,
- pregnancy,
- end of life.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
Mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Background: PubMed 12682500Levy 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.
- Background: PubMed 16003060Calandra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TALNA KORTCHINSKY, MD principal investigator
Centre Chirurgical Marie Lannelongue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Ventilator-Associated, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the ROC curve of the CPIS score (time frame: the previous 12 hours up to performance of pulmonary bacteriological samples). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02683122, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.