Early Aspiration PneumoniaNCT03007862
Bronchial Alpha Amylase as a Marker for Early Aspiration Pneumonia in Therapeutic Hypothermia.
An observational study of Early Aspiration Pneumonia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without use of a reliable screening biological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Aspiration Pneumonia
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to May 2019
- 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: Early Aspiration Pneumonia after out-of-hospital cardiac arrest treated with Therapeutic Temperature Management
Who may be able to join
- Well resuscitated patients after out-of-hospital cardiac arrest
- Indication of Therapeutic Temperature Management
- Patients aged over 18 years
- Immediate or deferred acceptation of study
Who cannot join
- Patients aged under 18 years.
- Pregnant women.
- Against indication to therapeutic hypothermia.
- Active therapeutic limitation after admission.
- Patient without social security.
Trial locations and contacts
1 site in 1 country.
Jeremy BOURENNE contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13005
Jeremy Bourenne
About this study
Official title: Salivary Alpha Amylase Bronchial Measure for Early Aspiration Pneumonia Diagnosis in Patients Treated With Therapeutic Hypothermia After Out-of-hospital Cardiac Arrest.
Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in patients successfully resuscitated after out-of-hospital cardiac arrest.
In this prospective non interventional study we included patients resuscitated after cardiac arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar lavage using specific display (Combi-Cath) was executed immediately after admission for each patient with both biochemic and bacteriological analysis including dosage of bronchial salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and biological criteria. On this basis we intended to determine a threshold measure of alpha amylase predicting occurrence of aspiration pneumonia and allowing a guidance in antibiotherapy prescription. Sensibility and Specificity of this technique were determined.
- Conditions
- Early Aspiration Pneumonia
- Medical subject headings
- Pneumonia, Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Aspiration Pneumonia
Diagnosis of aspiration pneumonia after cardiac arrest with clinical, biological and radiological criteria including fever, leucocytes, broncho alveolar secretion, chest radiography and bacteriological identification.
Measured: Within 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Aspiration PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007862
- Sponsor's protocol ID
- 2016-37
- Status last verified
- Dec 2016
- First submitted
- 28 Dec 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Alpha Amylase Bronchial Measure for Early Aspiration Pneumonia Diagnosis in Patients Treated With Therapeutic Hypothermia After Out-of-hospital Cardiac Arrest.
- ClinicalTrials.gov ID
- NCT03007862
- Acronym / sponsor ID
- 2016-37
- Conditions
- Early Aspiration Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 2 Jan 2017 (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.
Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in patients successfully resuscitated after out-of-hospital cardiac arrest.
In this prospective non interventional study we included patients resuscitated after cardiac arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar lavage using specific display (Combi-Cath) was executed immediately after admission for each patient with both biochemic and bacteriological analysis including dosage of bronchial salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and biological criteria. On this basis we intended to determine a threshold measure of alpha amylase predicting occurrence of aspiration pneumonia and allowing a guidance in antibiotherapy prescription. Sensibility and Specificity of this technique were determined.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early Aspiration Pneumonia after out-of-hospital cardiac arrest treated with Therapeutic Temperature Management
Key inclusion criteria (4 listed)
- Well resuscitated patients after out-of-hospital cardiac arrest
- Indication of Therapeutic Temperature Management
- Patients aged over 18 years
- Immediate or deferred acceptation of study
Key exclusion criteria (5 listed)
- Patients aged under 18 years.
- Pregnant women.
- Against indication to therapeutic hypothermia.
- Active therapeutic limitation after admission.
- Patient without social security.
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
Early Aspiration Pneumonia
Time frame: Within 5 days
Diagnosis of aspiration pneumonia after cardiac arrest with clinical, biological and radiological criteria including fever, leucocytes, broncho alveolar secretion, chest radiography and bacteriological identification.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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.
Jeremy BOURENNE contact
Urielle Desalbres study director
Assistance Publique Hôpitaux de Marseille
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 Early Aspiration Pneumonia, run by Assistance Publique Hopitaux De Marseille 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 4 inclusion and 5 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 10 Jan 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 Jeremy BOURENNE (jeremy.bourenne@sfr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Aspiration Pneumonia (time frame: Within 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2017.