Early Aspiration Pneumonia Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | May 2019 |
| Est. primary completion date | May 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Within 5 days | No |