Out-of-Hospital Cardiac ArrestPP-ACRNCT03355885
Early-onset Pneumonia After Out-of-hospital Cardiac Arrest
An observational study of Out-of-Hospital Cardiac Arrest, run by University Hospital, Brest at 1 site in France.
Trial summary
Early-onset pneumonia after out-of-hospital cardiac arrest is frequent. An association between early-onset pneumonia and an increase in morbidity has been reported in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2016to Jul 2018
- 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 admitted for out-of-hospital cardiac arrest in intensive care who and treated with hypothermia
Who may be able to join
- patients admitted for out-of-hospital cardiac arrest and treated with hypothermia
Who cannot join
- age less than 18
- consent withdrawal
Trial locations and contacts
1 site in 1 country.
Cecile Aubron, MD,PhD contact
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Cécile aubron, cecile.aubron@chu-brest.fr
About this study
Official title: Impact of Early Diagnosis Algorithm for Early-onset Pneumonia Diagnosis on Prognosis of Patients With Out-of-hospital Cardiac Arrest
Early-onset pneumonia after out-of-hospital cardiac arrest is frequent. An association between early-onset pneumonia and an increase in morbidity has been reported in this population. The diagnosis of early-onset pneumonia inpatients with out-of-hospital cardiac arrest may be challenging as diagnosis criteria are unspecific in this setting. On the other hand some studies have reported an association between early antibiotics and better prognosis in patients with out-of-hospital cardiac arrest suggesting that early diagnosis and treatment of pneumonia would benefit to patients. Nonetheless, adminitration of antibiotics to any patients with out-of-hospital cardiac arrest would expose to antibiotic patients without infection and woould participate to increase in antibiotic resistance.
Therefore, the PP-ACR study aims to evaluate the impact of a diagnosis algorithm including blinded sampling protected brushes on early-onset pneumonia treatment and patient prognosis after out-of-hospital cardiac arrest.
Read the detailed description
This study is a single centre observational study with a before - after design.
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- early onset pneumonia, out-of-hospital cardiac arrest, prognosis, antibiotic
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
delay between intensive care admission and antibiotic initiation
Measured: first 5 days
delta respiratory SOFA score between Day 1 and day 3
Measured: first 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start3 Oct 2016
- Primary completion31 May 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355885
- Sponsor's protocol ID
- PP-ACR
- Acronym
- PP-ACR
- Status last verified
- Oct 2017
- First submitted
- 23 Nov 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lemee P, Chapalain X, Bailly P, Sparrow RL, Jean-Michel V, Prat G, Renault A, Tonnelier JM, Aubron C. PROACTIVE SCREENING ALGORITHM FOR EARLY-ONSET PNEUMONIA IN PATIENTS WITH OUT-OF-HOSPITAL CARDIAC ARREST: A BEFORE-AFTER IMPLEMENTATION STUDY. Shock. 2024 Jul 1;62(1):13-19. doi: 10.1097/SHK.0000000000002347. Epub 2024 Mar 25.
PubMed 38661180
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Diagnosis Algorithm for Early-onset Pneumonia Diagnosis on Prognosis of Patients With Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03355885
- Acronym / sponsor ID
- PP-ACR / PP-ACR
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- early onset pneumonia, out-of-hospital cardiac arrest, prognosis, antibiotic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 28 Nov 2017 (actual)
- 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.
Early-onset pneumonia after out-of-hospital cardiac arrest is frequent. An association between early-onset pneumonia and an increase in morbidity has been reported in this population. The diagnosis of early-onset pneumonia inpatients with out-of-hospital cardiac arrest may be challenging as diagnosis criteria are unspecific in this setting. On the other hand some studies have reported an association between early antibiotics and better prognosis in patients with out-of-hospital cardiac arrest suggesting that early diagnosis and treatment of pneumonia would benefit to patients. Nonetheless, adminitration of antibiotics to any patients with out-of-hospital cardiac arrest would expose to antibiotic patients without infection and woould participate to increase in antibiotic resistance.
Therefore, the PP-ACR study aims to evaluate the impact of a diagnosis algorithm including blinded sampling protected brushes on early-onset pneumonia treatment and patient prognosis after out-of-hospital cardiac arrest.
Detailed description
This study is a single centre observational study with a before - after design.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted for out-of-hospital cardiac arrest in intensive care who and treated with hypothermia
Key inclusion criteria (1 listed)
- patients admitted for out-of-hospital cardiac arrest and treated with hypothermia
Key exclusion criteria (2 listed)
- age less than 18
- consent withdrawal
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
delay between intensive care admission and antibiotic initiation
Time frame: first 5 days
delta respiratory SOFA score between Day 1 and day 3
Time frame: first 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Derived from this study: PubMed 38661180Lemee P, Chapalain X, Bailly P, Sparrow RL, Jean-Michel V, Prat G, Renault A, Tonnelier JM, Aubron C. PROACTIVE SCREENING ALGORITHM FOR EARLY-ONSET PNEUMONIA IN PATIENTS WITH OUT-OF-HOSPITAL CARDIAC ARREST: A BEFORE-AFTER IMPLEMENTATION STUDY. Shock. 2024 Jul 1;62(1):13-19. doi: 10.1097/SHK.0000000000002347. Epub 2024 Mar 25.
- 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.
Cecile Aubron, MD,PhD contact
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 Out-of-Hospital Cardiac Arrest, run by University Hospital, Brest 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecile Aubron, MD,PhD (cecile.aubron@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delay between intensive care admission and antibiotic initiation (time frame: first 5 days). The study lists 2 primary outcomes in all. 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 NCT03355885, which also lists 1 linked publication.
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 29 Nov 2017.