Bronchial Alpha Amylase as a Marker for Early Aspiration Pneumonia in Therapeutic Hypothermia.

NCT ID: NCT03007862

Last Updated: 2017-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Early Aspiration Pneumonia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients aged under 18 years.
* Pregnant women.
* Against indication to therapeutic hypothermia.
* Active therapeutic limitation after admission.
* Patient without social security.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urielle Desalbres

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

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Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jeremy BOURENNE

Role: CONTACT

Facility Contacts

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Jeremy Bourenne

Role: primary

Other Identifiers

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2016-37

Identifier Type: -

Identifier Source: org_study_id

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