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

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ClinicalTrials.gov Identifier: NCT03007862
Recruitment Status : Unknown
Verified December 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : January 2, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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 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.


Condition or disease
Early Aspiration Pneumonia

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Salivary Alpha Amylase Bronchial Measure for Early Aspiration Pneumonia Diagnosis in Patients Treated With Therapeutic Hypothermia After Out-of-hospital Cardiac Arrest.
Study Start Date : November 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Early Aspiration Pneumonia after out-of-hospital cardiac arrest treated with Therapeutic Temperature Management
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007862


Contacts
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Contact: Jeremy BOURENNE jeremy.bourenne@sfr.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13005
Contact: Jeremy Bourenne         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle Desalbres Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03007862     History of Changes
Other Study ID Numbers: 2016-37
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Aspiration
Hypothermia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Body Temperature Changes
Signs and Symptoms