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

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ClinicalTrials.gov Identifier: NCT01269177
Recruitment Status : Unknown
Verified October 2010 by University of Milan.
Recruitment status was:  Recruiting
First Posted : January 4, 2011
Last Update Posted : January 4, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Pulmonary Edema Respiratory Insufficiency Device: Non invasive ventilation

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
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study
Study Start Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

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



Primary Outcome Measures :
  1. mortality [ Time Frame: Discharge from hospital ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the Emergency Department with acute cardiogenic pulmonary edema
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269177


Locations
Italy
Fondazione IRCCS Ospedale Maggiore Policinico, Mangiagalli e Regina Elena Recruiting
Milano, Italy, 20100
Contact: Roberto Cosentini, MD    +39 02 55033610    roberto.cosentini@policlinico.mi.it   
Principal Investigator: Roberto Cosentini, MD         
Sponsors and Collaborators
University of Milan
Investigators
Study Chair: Roberto Cosentini, MD Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Additional Information:
Publications:
Responsible Party: Roberto Cosentini, MD, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli, Regina Elena
ClinicalTrials.gov Identifier: NCT01269177     History of Changes
Other Study ID Numbers: ACPE.IT
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: October 2010

Keywords provided by University of Milan:
ACPE
Acute respiratory failure
Non invasive ventilation
acute cardiogenic pulmonary edema

Additional relevant MeSH terms:
Edema
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Pulmonary Edema
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Lung Diseases