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
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|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007862
|Contact: Jeremy BOURENNEfirstname.lastname@example.org|
|Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille, France, 13005|
|Contact: Jeremy Bourenne|
|Study Director:||Urielle Desalbres||Assistance Publique Hôpitaux de Marseille|