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

January 3, 2011 updated by: University of Milan
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20100
        • Recruiting
        • Fondazione IRCCS Ospedale Maggiore Policinico, Mangiagalli e Regina Elena
        • Contact:
        • Principal Investigator:
          • Roberto Cosentini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to the Emergency Department with acute cardiogenic pulmonary edema

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute cardiogenic pulmonary edema
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: Discharge from hospital
Discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Study Chair: Roberto Cosentini, MD, Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

January 4, 2011

Last Update Submitted That Met QC Criteria

January 3, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACPE.IT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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