Clinical trial NCT03148847: Management of Cardiogenic Pulmonary Edema (RENAU-OAP)
Official title: Evaluation of Professional Practices on the Management of Cardiogenic Pulmonary Edema (RENAU-OAP)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dyspnea, Paroxysmal
Heart Failure, Left Sided
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 859
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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).

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.

Detailed description: The prevalence of heart failure is estimated to 2.3 percent of the adult population and strongly increases with age, according to disability-health surveys in France. In recent years, effective treatments (revascularization in percutaneous coronary intervention, circulatory assistance) helped reduce mortality in post-myocardial infarction, which combined with the increase of life expectancy has led to an increase number of patients with chronic heart failure. More than 32,000 annual deaths are attributable to heart failure and the five-year survival rate is similar to those found in cancers of the breast, bladder, colon, ovarian, and prostate. 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.

Main clinical manifestations are those of left heart failure, such as cardiogenic pulmonary edema which is a medical emergency. Treatment must take into account pathophysiological aspects of heart failure, etiologies of cardiogenic pulmonary edema and any potential factors or triggers apart from general measures. Two consensus statements and an international recommendation help define therapeutic strategies in this particular situation.

Signs suggestive of cardiogenic pulmonary edema include orthopnea, bilateral crackles or wheezing (patients over 70 years without known asthma), edema of the lower limbs, and gallop sound on heart auscultation. The evolution of these signs makes it particularly possible to manage the response to the treatment. The severity of cardiogenic pulmonary edema depends on several factors such as etiology (ECG analysis and chest pain assessment for acute coronary syndrome), hemodynamic status (blood pressure, heart rate), effect on hematosis (cyanosis, oxygen saturation), and fatigue (low respiratory rate with persistent cardiogenic pulmonary edema signs). The respiratory rate represents a simple clinical feature that can be used to quantify dyspnea (sign of severity if greater than 30 per minute in adults) and then follow its evolution (improvement, exhaustion). Disorders of consciousness can testify to the severity of the hemodynamic state and/or exhaustion.

Cardiogenic pulmonary edema management without shock implies urgent administration of vasodilators (trinitrin) and intravenous loop diuretics in presence of congestion signs along with the establishment of a system of care adapted to severity (Emergency Mobile Services or ambulance, hospitalization in Intensive Care Unit, intensive cardiology unit, cardiology or medicine department, or emergency passage). The subsequent therapeutic management will especially depend on initial treatment by the primary care physician, so it is preferable to record doses and hours of medications. Non-hospitalization must remain exceptional for non-severe decompensation with rapidly favorable evolution.

The French Observatory of Acute Heart Failure (OFICA) including nearly 1,800 patients specified epidemiological and therapeutic data of patients hospitalized for cardiogenic pulmonary edema in 2009. However, this study did not describe the initial management of the Mobile Emergency and Resuscitation Service and emergency services of hospitals. 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 a guideline on cardiogenic pulmonary edema management which will then be assessed.

Eligibility 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

Primary outcomes:
measure: Change of quality of initial care of patients with cardiogenic pulmonary edema after dissemination of good practice standards
timeFrame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Secondary outcomes:
measure: Patients' description at the onset of cardiogenic pulmonary edema (clinical)
timeFrame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
measure: Patients' description at the onset of cardiogenic pulmonary edema (biological)
timeFrame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
measure: Patients' description at the onset of cardiogenic pulmonary edema (radiological)
timeFrame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
measure: Patients' description at the onset of cardiogenic pulmonary edema (echocardiographic)
timeFrame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
measure: Mortality of patients hospitalized for cardiogenic pulmonary edema
timeFrame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
measure: Needs for Hospitalization in intensive care units
timeFrame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
measure: Needs for respiratory assistance
timeFrame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
measure: Inter-services transfers
timeFrame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
measure: Length of stay in hospital
timeFrame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
measure: Re-hospitalizations during the first six months
timeFrame: up to six months
Other outcomes:
Locations:
city: Pringy
country: France
facility: CH Annecy Genevois
Study officials:
affiliation: Centre Hospitalier Annecy Genevois
name: Loic BELLE, MD
role: STUDY_CHAIR
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