Study Stopped
Only the first part of the study was done.
Management of Cardiogenic Pulmonary Edema (RENAU-OAP)
RENAU-OAP
Evaluation of Professional Practices on the Management of Cardiogenic Pulmonary Edema (RENAU-OAP)
Sponsor study identifier
observational
859
1 country
1
Study Start
January 2015
Actual (reported)Primary Completion
December 2016
Actual (reported)Study Completion
January 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Actual (reported)December 2016
Actual (reported)May 2, 2017
Actual (reported)May 11, 2017
Actual (reported)January 2018
Actual (reported)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)
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)
Patients treated for Cardiogenic Pulmonary Edema into the Northern French Alps Emergency Network between January 1, 2013 and December 31, 2013
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).
CH Annecy Genevois
Pringy, F-74374, France
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.
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.
Loic BELLE, MD
Centre Hospitalier Annecy Genevois
859 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2017
First Posted
May 11, 2017
Study Start
January 2015
Actual (reported)Effect of Left Ventricle Diastolic Dysfunction on Outcomes in Female Cardiac Surgery Patients
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Logeart D. [The OFICA study of acute heart failure]. Soins. 2013 Apr;(774):35. No abstract available. French.
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.
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.
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.
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.
Primary Completion
December 2016
Actual (reported)Study Completion
January 2018
Actual (reported)Last Updated
June 18, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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