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

• Conditions: Pulmonary Edema; Respiratory Insufficiency
• Interventions: Device: Non invasive ventilation

• Registration Number: NCT01269177
• Lead Sponsor: University of Milan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-05
• Status Verified: 2010-10
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Last Update Submitted: 2011-01-03
• Study First Posted: 2011-01-04
• Last Update Posted: 2011-01-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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%

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with acute cardiogenic pulmonary edema	Non invasive ventilation	-

Primary Outcome Measures

Name	Time	Method
mortality	Discharge from hospital

Trial Locations

Locations (1)

Fondazione IRCCS Ospedale Maggiore Policinico, Mangiagalli e Regina Elena; 🇮🇹 Milano, Italy