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
  Purpose

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 Intervention
Pulmonary Edema
Respiratory Insufficiency
Device: Non invasive ventilation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • mortality [ Time Frame: Discharge from hospital ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: May 2009
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
  More Information

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
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: Italy: Ethics Committee

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 Edema
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on September 22, 2014