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

U

University of Milan

Status

Unknown

Conditions

Respiratory Insufficiency
Pulmonary Edema

Treatments

Device: Non invasive ventilation

Study type

Observational

Funder types

Other

Identifiers

NCT01269177
ACPE.IT

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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%

Trial design

1,000 participants in 1 patient group

Patients with acute cardiogenic pulmonary edema
Treatment:
Device: Non invasive ventilation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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