Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03007862
Other study ID # 2016-37
Secondary ID
Status Recruiting
Phase N/A
First received December 28, 2016
Last updated January 9, 2017
Start date November 2016
Est. completion date May 2019

Study information

Verified date December 2016
Source Assistance Publique Hopitaux De Marseille
Contact Jeremy BOURENNE
Email jeremy.bourenne@sfr.fr
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

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