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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Milan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT01269177
First received: January 3, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted

January 3, 2011
January 3, 2011
May 2009
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mortality [ Time Frame: Discharge from hospital ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study
Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample

Patients admitted to the Emergency Department with acute cardiogenic pulmonary edema

  • Pulmonary Edema
  • Respiratory Insufficiency
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
Patients with acute cardiogenic pulmonary edema
Intervention: Device: Non invasive ventilation
Cosentini R, Aliberti S, Bignamini A, Piffer F, Brambilla AM. Mortality in acute cardiogenic pulmonary edema treated with continuous positive airway pressure. Intensive Care Med. 2009 Feb;35(2):299-305. Epub 2008 Sep 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
Not Provided

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%
Both
18 Years and older
No
Italy
 
NCT01269177
ACPE.IT
Not Provided
Roberto Cosentini, MD, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli, Regina Elena
University of Milan
Not Provided
Study Chair: Roberto Cosentini, MD Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
University of Milan
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP