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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01269177

Acronym

ACPE

Enrollment

1000

Registered

2011-01-04

Start date

2009-05-31

Completion date

Unknown

Last updated

2011-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Edema, Respiratory Insufficiency

Keywords

ACPE, Acute respiratory failure, Non invasive ventilation, acute cardiogenic pulmonary edema

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.

Interventions

DEVICENon 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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%

Design outcomes

Primary

Measure	Time frame
mortality	Discharge from hospital

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026