Management of Cardiogenic Pulmonary Edema (RENAU-OAP)

NCT03148847 | Terminated

• 1 other identifier: 2014-RENAU-1
• Study Type: observational
• Target: 859
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea, Paroxysmal; Heart Failure, Left Sided

Outcome Measures

Primary Outcomes (1)

• Change of quality of initial care of patients with cardiogenic pulmonary edema after dissemination of good practice standards

  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).

  an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)

Secondary Outcomes (10)

• Patients' description at the onset of cardiogenic pulmonary edema (clinical)

  an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)

• Patients' description at the onset of cardiogenic pulmonary edema (biological)

  an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)

• Patients' description at the onset of cardiogenic pulmonary edema (radiological)

  an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)

• Patients' description at the onset of cardiogenic pulmonary edema (echocardiographic)

  an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)

• Mortality of patients hospitalized for cardiogenic pulmonary edema

  an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)

Study Arms (2)

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

Interventions

Baseline care OTHER

Baseline care

Referential's dissemination OTHER

Referential's dissemination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

Study Sites (1)

CH Annecy Genevois

Pringy, F-74374, France

Location

Related Publications (22)

• Stewart S, MacIntyre K, Hole DJ, Capewell S, McMurray JJ. More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail. 2001 Jun;3(3):315-22. doi: 10.1016/s1388-9842(00)00141-0.

  PMID: 11378002 BACKGROUND

• Mebazaa A, Gheorghiade M, Pina IL, Harjola VP, Hollenberg SM, Follath F, Rhodes A, Plaisance P, Roland E, Nieminen M, Komajda M, Parkhomenko A, Masip J, Zannad F, Filippatos G. Practical recommendations for prehospital and early in-hospital management of patients presenting with acute heart failure syndromes. Crit Care Med. 2008 Jan;36(1 Suppl):S129-39. doi: 10.1097/01.CCM.0000296274.51933.4C.

  PMID: 18158472 BACKGROUND

• Heart Failure Society Of America. HFSA 2006 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2006 Feb;12(1):e1-2. doi: 10.1016/j.cardfail.2005.11.005.

  PMID: 16500560 BACKGROUND

• McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.

  PMID: 22611136 BACKGROUND

• Emerman CL. Treatment of the acute decompensation of heart failure: efficacy and pharmacoeconomics of early initiation of therapy in the emergency department. Rev Cardiovasc Med. 2003;4 Suppl 7:S13-20.

  PMID: 14668696 BACKGROUND

• Peacock WF 4th, Emerman CL. Emergency department management of patients with acute decompensated heart failure. Heart Fail Rev. 2004 Jul;9(3):187-93. doi: 10.1007/s10741-005-6128-5.

  PMID: 15809816 BACKGROUND

• Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

  PMID: 11794169 BACKGROUND

• Belle L, Fourny M, Reynaud T, Hammer L, Vanzetto G, Labarere J; RENAU-RESURCOR study investigators. Efficacy and safety of glycoprotein IIb/IIIa receptor antagonists for patients undergoing percutaneous coronary intervention within twelve hours of fibrinolysis. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):376-84. doi: 10.1002/ccd.22825. Epub 2011 Mar 16.

  PMID: 21413113 BACKGROUND

• Chacornac M, Baronne-Rochette G, Schmidt MH, Savary D, Habold D, Bouvaist H, Marliere S, Belle L, Machecourt J, Vanzetto G; REseau des URgences CORonariennes (RESURCOR). Characteristics and management of acute ST-segment elevation myocardial infarctions occurring in ski resorts in the French Alps: Impact of an acute coronary care network. Arch Cardiovasc Dis. 2010 Aug-Sep;103(8-9):460-8. doi: 10.1016/j.acvd.2010.09.002. Epub 2010 Oct 30.

  PMID: 21074125 BACKGROUND

• Debaty G, Belle L, Labarere J, Fourny M, Torres JP, Savary D, Usseglio P, Menthonnex E, Guenot O, Vanzetto G. [Evolution of strategies of revascularisation in acute coronary syndromes with ST elevation. Analysis of the data of RESURCOR]. Arch Mal Coeur Vaiss. 2007 Feb;100(2):105-11. French.

  PMID: 17474495 BACKGROUND

• Ferrier C, Belle L, Labarere J, Fourny M, Vanzetto G, Guenot O, Debaty G, Savary D, Machecourt J, Francois P. [Comparison of mortality according to the revascularisation strategies and the symptom-to-management delay in ST-segment elevation myocardial infarction]. Arch Mal Coeur Vaiss. 2007 Jan;100(1):13-9. French.

  PMID: 17405549 BACKGROUND

• Fourny M, Belle L, Labarere J, Senee D, Savary D, Debaty G, Vanzetto G, Francois P. [Analysis of the accuracy of a coronary syndrome register]. Arch Mal Coeur Vaiss. 2006 Sep;99(9):798-803. French.

  PMID: 17067098 BACKGROUND

• Fourny M, Lucas AS, Belle L, Debaty G, Casez P, Bouvaist H, Francois P, Vanzetto G, Labarere J. Inappropriate dispatcher decision for emergency medical service users with acute myocardial infarction. Am J Emerg Med. 2011 Jan;29(1):37-42. doi: 10.1016/j.ajem.2009.07.008. Epub 2010 Mar 9.

  PMID: 20825772 BACKGROUND

• Zannad F, Briancon S, Juilliere Y, Mertes PM, Villemot JP, Alla F, Virion JM. Incidence, clinical and etiologic features, and outcomes of advanced chronic heart failure: the EPICAL Study. Epidemiologie de l'Insuffisance Cardiaque Avancee en Lorraine. J Am Coll Cardiol. 1999 Mar;33(3):734-42. doi: 10.1016/s0735-1097(98)00634-2.

  PMID: 10080475 RESULT

• Delahaye F, Roth O, Aupetit JF, de Gevigney G. [Epidemiology and prognosis of cardiac insufficiency]. Arch Mal Coeur Vaiss. 2001 Dec;94(12):1393-403. French.

  PMID: 11828925 RESULT

• Schaufelberger M, Swedberg K, Koster M, Rosen M, Rosengren A. Decreasing one-year mortality and hospitalization rates for heart failure in Sweden; Data from the Swedish Hospital Discharge Registry 1988 to 2000. Eur Heart J. 2004 Feb;25(4):300-7. doi: 10.1016/j.ehj.2003.12.012.

  PMID: 14984918 RESULT

• Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.

  PMID: 23186936 RESULT

• Logeart D. [The OFICA study of acute heart failure]. Soins. 2013 Apr;(774):35. No abstract available. French.

  PMID: 23697057 RESULT

• Nguyen HB, Rivers EP, Havstad S, Knoblich B, Ressler JA, Muzzin AM, Tomlanovich MC. Critical care in the emergency department: A physiologic assessment and outcome evaluation. Acad Emerg Med. 2000 Dec;7(12):1354-61. doi: 10.1111/j.1553-2712.2000.tb00492.x.

  PMID: 11099425 RESULT

• Sebat F, Johnson D, Musthafa AA, Watnik M, Moore S, Henry K, Saari M. A multidisciplinary community hospital program for early and rapid resuscitation of shock in nontrauma patients. Chest. 2005 May;127(5):1729-43. doi: 10.1378/chest.127.5.1729.

  PMID: 15888853 RESULT

• Masip J, Roque M, Sanchez B, Fernandez R, Subirana M, Exposito JA. Noninvasive ventilation in acute cardiogenic pulmonary edema: systematic review and meta-analysis. JAMA. 2005 Dec 28;294(24):3124-30. doi: 10.1001/jama.294.24.3124.

  PMID: 16380593 RESULT

• Peter JV, Moran JL, Phillips-Hughes J, Graham P, Bersten AD. Effect of non-invasive positive pressure ventilation (NIPPV) on mortality in patients with acute cardiogenic pulmonary oedema: a meta-analysis. Lancet. 2006 Apr 8;367(9517):1155-63. doi: 10.1016/S0140-6736(06)68506-1.

  PMID: 16616558 RESULT

MeSH Terms

Conditions

Dyspnea, Paroxysmal; Heart Failure

Condition Hierarchy (Ancestors)

Dyspnea; Respiration Disorders; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Loic BELLE, MD

  Centre Hospitalier Annecy Genevois

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 11, 2017
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2018
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)