Pulmonary EdemaACPENCT01269177
Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study
An observational study of Pulmonary Edema and Respiratory Insufficiency, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Edema, Respiratory Insufficiency
- What is being tested?
- Non invasive ventilation
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Emergency Department with acute cardiogenic pulmonary edema
Who may be able to join
- 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%
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ospedale Maggiore Policinico, Mangiagalli e Regina Elena
Milan, Italy, 20100
Roberto Cosentini, MD, +39 02 55033610, roberto.cosentini@policlinico.mi.it
Roberto Cosentini, MD
About this 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.
Read the 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.
- Conditions
- Pulmonary Edema, Respiratory Insufficiency
- Being tested
- Non invasive ventilation
- Keywords
- ACPE, Acute respiratory failure, Non invasive ventilation, acute cardiogenic pulmonary edema
- Medical subject headings
- Pulmonary Edema, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ventilationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute cardiogenic pulmonary edema | Not described Receives: Device: Non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: Discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Investigators
- Roberto Cosentini, MD, Study chair, Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269177
- Sponsor's protocol ID
- ACPE.IT
- Acronym
- ACPE
- Status last verified
- Oct 2010
- First submitted
- 3 Jan 2011
- Last updated
- 4 Jan 2011
- Results posted
- No
Publications
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. doi: 10.1007/s00134-008-1281-7. Epub 2008 Sep 20.
PubMed 18807009
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study
- ClinicalTrials.gov ID
- NCT01269177
- Acronym / sponsor ID
- ACPE / ACPE.IT
- Conditions
- Pulmonary Edema, Respiratory Insufficiency
- Keywords
- ACPE, Acute respiratory failure, Non invasive ventilation, acute cardiogenic pulmonary edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- May 2009
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute cardiogenic pulmonary edema | – | Device: Non invasive ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Emergency Department with acute cardiogenic pulmonary edema
Key inclusion criteria (8 listed)
- age ≥ 18
- acute-onset dyspnea
- widespread pulmonary rales
- pulmonary congestion on chest X- ray plus one of the following:
- respiratory distress
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive ventilationIndications 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 | Device | Patients with acute cardiogenic pulmonary edema |
Primary outcome
mortality
Time frame: Discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2011.
- Background: PubMed 18807009Cosentini 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. doi: 10.1007/s00134-008-1281-7. Epub 2008 Sep 20.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fondazione IRCCS Ospedale Maggiore Policinico, Mangiagalli e Regina Elena
Milan, Italy
Roberto Cosentini, MD study chair
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Edema and Respiratory Insufficiency, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: Discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01269177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2011.