Clinical Trial: Management of Cardiogenic Pulmonary Edema (RENAU-OAP)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Evaluation of Professional Practices on the Management of Cardiogenic Pulmonary Edema (RENAU-OAP)

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 Summary:

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,
Sponsor: Centre Hospitalier de la Région d'Annecy

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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).
  • 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).
  • 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).
  • 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).
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier de la Région d'Annecy

Dates:
Date Received: May 2, 2017
Date Started: January 2015
Date Completion: December 2019
Last Updated: May 9, 2017
Last Verified: May 2017