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NCT01269177 Clinical Trial

Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study

Respiratory Insufficiency Clinical Trial

— ACPE  

Official title:
Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01269177
Other study ID # ACPE.IT
Secondary ID
Status Recruiting
Phase N/A
First received January 3, 2011
Last updated January 3, 2011
Start date May 2009

Study information
Verified date October 2010
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to define the current treatment of patients ospitalized with acute cardiogenic pulmonary edema. Clinical and laboratory data collected in the Emergency Department will used to investigate the primary outcome (mortality) and risk factors related to the primary outcome.

Description:

ACPE is a common cause of presentation to the Emergency Department (ED). Early recognition of high-risk patients could help in better locating human and technical resources and in deciding adequate treatment and site of care.

The investigators planned a real life, multicentric, prospective, web-based observational study performed in Italian Emergency Departments.

The investigators enroll consecutive patients admitted to the Emergency Department with acute cardiogenic pulmonary edema, that is defined as all the following: respiratory distress, bilateral rales and congestion on chest X-ray.

Demographic, clinical and laboratory findings are collected on admission and during hospitalization to evaluate mortality and risk factors related to mortality.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

all of the following:

- age = 18

- acute-onset dyspnea

- widespread pulmonary rales

- pulmonary congestion on chest X- ray plus one of the following:

- respiratory distress

- respiratory rate = 30

- emogasanalysis: pH < 7.35 and pCO2 > 45 mmHg in Venturi-Mask 50%

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Non invasive ventilation
Indications for the use of NIV are at least one of the following: Respiratory Rate = 30 bpm PaO2/FiO2 < 200 pH < 7.35 and PaCO2 > 45 mmH Contraindications for the use of NIV are at least one of the following: Coma Hemodynamic instability / shock Lack of compliance Indications for endotracheal intubation (ETI) are at least one of the following: Respiratory or cardiac arrest Coma Hemodynamic instability

Locations
Country Name City State
Italy Fondazione IRCCS Ospedale Maggiore Policinico, Mangiagalli e Regina Elena Milano

Sponsors (1)
Lead Sponsor Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Cosentini R, Aliberti S, Bignamini A, Piffer F, Brambilla AM. Mortality in acute cardiogenic pulmonary edema treated with continuous positive airway pressure. Intensive Care Med. 2009 Feb;35(2):299-305. doi: 10.1007/s00134-008-1281-7. Epub 2008 Sep 20. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary mortality Discharge from hospital No
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