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Management of Cardiogenic Pulmonary Edema (RENAU-OAP) (RENAU-OAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03148847
Recruitment Status : Terminated (Only the first part of the study was done.)
First Posted : May 11, 2017
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Annecy Genevois

Brief Summary:

The prevalence of heart failure is estimated to 2.3 percent of the adult population and strongly increases with age, according to french disability-health surveys. In France, more than 32,000 annual deaths are attributable to heart failure and the five-year survival rate is similar to those found in many cancers. A better therapeutic management (angiotensin converting enzyme inhibitor and beta-blockers) helped reduce mortality after an episode of heart failure requiring hospitalization, but, nevertheless it remains high.

The severity of cardiogenic pulmonary edema depends on several factors such as etiology, hemodynamic status, effect on hematosis, and fatigue.

It is important to note that cardiogenic pulmonary edema initial management is decisive. In addition, early and adapted management of cardiogenic pulmonary edema is associated with a shorter hospital stay and reduced hospital mortality.

The Coronary Emergency Network (RESURCOR) within the Northern French Alps Emergency Network (RENAU) is an emergency care system structured in the departments of Isère, Savoie and Haute Savoie. Its main goal is to help improve emergency management by using regional good practice guidelines (www.renau.org). In this context, projects aiming to evaluate professional practices are developed regularly. Since emergency management of cardiogenic pulmonary edema has not been evaluated, the Northern French Alps Emergency Network offers an approach to improve professional practices by defining and disseminating guidelines on cardiogenic pulmonary edema management which will then be assessed.


Condition or disease Intervention/treatment
Dyspnea, Paroxysmal Heart Failure, Left Sided Other: Baseline care Other: Referential's dissemination

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Study Type : Observational
Actual Enrollment : 859 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of Professional Practices on the Management of Cardiogenic Pulmonary Edema (RENAU-OAP)
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort Intervention/treatment
Baseline care
Patients treated for Cardiogenic Pulmonary Edema into the Northern French Alps Emergency Network between January 1, 2013 and December 31, 2013
Other: Baseline care
Referential's dissemination
Patients treated for Cardiogenic Pulmonary Edema into the Northern French Alps Emergency Network between January 1, 2017 and December 31, 2017, after referential's dissemination for management of patients with paroxysmal dyspnea due to left sided heart failure
Other: Referential's dissemination



Primary Outcome Measures :
  1. Change of quality of initial care of patients with cardiogenic pulmonary edema after dissemination of good practice standards [ Time Frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema) ]
    Two kinds of predefined quality indicators will be evaluated at different stages of care and compared among the two periods, before and after dissemination of good practice standards, looking for informations in medical charts during the management of patients either care by Mobile Emergency and Resuscitation Services or at emergency departments and in mails at time of hospital discharge).


Secondary Outcome Measures :
  1. Patients' description at the onset of cardiogenic pulmonary edema (clinical) [ Time Frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema) ]
    Clinical characteristics of patients with cardiogenic pulmonary edema included in the two parts of this observational study (whole population).

  2. Patients' description at the onset of cardiogenic pulmonary edema (biological) [ Time Frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema) ]
    Biological characteristics of patients with cardiogenic pulmonary edema included in the two parts of this observational study (whole population).

  3. Patients' description at the onset of cardiogenic pulmonary edema (radiological) [ Time Frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema) ]
    Radiological characteristics of patients with cardiogenic pulmonary edema included in the two parts of this observational study (whole population).

  4. Patients' description at the onset of cardiogenic pulmonary edema (echocardiographic) [ Time Frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema) ]
    Echocardiographic characteristics of patients with cardiogenic pulmonary edema included in the two parts of this observational study (whole population).

  5. Mortality of patients hospitalized for cardiogenic pulmonary edema [ Time Frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema) ]
    number of patients dying during hospitalization for cardiogenic pulmonary edema

  6. Needs for Hospitalization in intensive care units [ Time Frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema) ]
    number (and rate) of patients with cardiogenic pulmonary edema, requiring hospitalization in intensive care unit

  7. Needs for respiratory assistance [ Time Frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema) ]
    number of patients and kind of respiratory assistance for patients with cardiogenic pulmonary edema

  8. Inter-services transfers [ Time Frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema) ]
    number of patients who require transfers from an emergency room (or a cardiology ward) to intensive care units and vice-versa

  9. Length of stay in hospital [ Time Frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema) ]
    number of days between arrival and discharge

  10. Re-hospitalizations during the first six months [ Time Frame: up to six months ]
    number of re-hospitalizations during the first six months after the onset of cardiogenic pulmonary edema



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

As the goal of this study is to analyze common practices, data from the french medicalized information system program will be used to select a study population as exhaustive as possible.

This program is dedicated to systematic collection of data from hospital stays. Each hospital stay is identified by a unique number and a diagnosis is attributed for each, at the end of every hospital stay. Diagnosis are based on the International Classification of Diseases (ICD-10). At hospital levels, a unique stay number can be related to names and addresses of involved patients.

French medicalized information system program data are analyzed at a regional and then a national level.

For this study, cases will be screened if they had a I500, I501 and I509 ICD-10 diagnosis (main or associated).

Criteria

Inclusion Criteria:

  • ≥18 years old
  • hospitalization during one of the two designed period (either year 2013, or year 2017) in a center belonging to Northern French Alps Emergency Network
  • diagnosis of cardiogenic pulmonary edema, or heart failure (either left-sided, congestive or unspecified)

Exclusion Criteria:

  • people who refuse to have their health information used will not be included
  • people whose care will have begun in a center not belonging to the Northern French Alps Emergency Network

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): NCT03148847


Locations
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France
CH Annecy Genevois
Pringy, France, F-74374
Sponsors and Collaborators
Centre Hospitalier Annecy Genevois
Investigators
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Study Chair: Loic BELLE, MD Centre Hospitalier Annecy Genevois
Publications of Results:

Other Publications:

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Responsible Party: Centre Hospitalier Annecy Genevois
ClinicalTrials.gov Identifier: NCT03148847    
Other Study ID Numbers: 2014-RENAU-1
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspnea
Pulmonary Edema
Dyspnea, Paroxysmal
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Lung Diseases