French Observatory on the Management of Cardiogenic Shock in 2016

NCT02703038 | Completed

• 1 other identifier: 15897
• Study Type: observational
• Target: 777
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiogenic shock (CS) is defined as an organ hypoperfusion secondary to low cardiac output. Catches diagnostic management, and therapeutic monitoring of these patients remain highly variable from one center to another and even from one doctor to another within the same team. The management protocols are often not standardized or non-existent. It appears therefore necessary to make an inventory of the management practices of the CS in France in 2016, prerequisite to a common work of standardization of practices and the creation of specialized networks to support these complex patients.

Conditions

Shock, Cardiogenic

Keywords

cardiogenic shock; observatory

Outcome Measures

Primary Outcomes (1)

• Mortality at day 30

  Death rate at 30 days of follow-up

  30 days

Secondary Outcomes (2)

• Analysis of mortality at day 30 by subgroup on age, sex, NYHA grade, initial etiology

  30 days

• Mortality at 1 year

  1 year

Study Arms (1)

Cardiogenic shock

Patient with cardiogenic shock table defined by the combination of a low cardiac output even as the filling pressures are normal or high, originally of hypoperfusion and organ suffering.

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

Adult patient (\> 18 years) with cardiogenic shock table defined by the combination of a low cardiac output even as the filling pressures are normal or high, originally of hypoperfusion and suffering of organ.

You may qualify if:

• Informed consent
• Cardiogenic shock authenticated by the existence of at least one positive test for each of the following three parts:
• (A) Low cardiac output (1 criterion necessary and sufficient):
• Clinic: SBP \<90mmHg and / or need to maintain inotropic or vasopressor to maintain SBP\> 90 mmHg
• Echocardiography: IC \<2.2L / min / m2 and / or LVEF \<30%
• Hemodynamics by Swan Ganz catheterization or right: IC 2.2 l / min / m2 (B) elevation of pulmonary pressure / left surcharge (1 criterion necessary and sufficient):
• Clinical (IVD and abortion);
• Radiological (Surcharge on RT or chest CT);
• Organic (NTproBNP\> 900pg / ml or BNP\> 400pg / ml);
• Echocardiography (E / A\> 2 if LVEF \<45% or E / Ea\> 13 if normal LVEF, or PAPS\> 35mmHg and / or TDE \<150ms and / or Ap-Am\> 30ms and / or E / 2 Vp≥ , 5);
• Right Swan Ganz catheterization or (pulmonary capillary pressures\> 15mmHg and / or mPAP\> 25mmHg)
• (C) Organs malperfusion (1 criterion necessary and sufficient):
• Clinic: oliguria \<30ml / kg / h, mottling, consciousness disorders)
• Organic: arterial lactate\> 2 mmol / L, liver failure, kidney failure

You may not qualify if:

• Final diagnosis retained other than cardiogenic shock
• Cardiac arrest without spontaneous activity in the hospital management
• Post-cardiotomy cardiogenic shock
• Deprived of liberty patient
• Refusal or lack of consent

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

Location

Related Publications (26)

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• Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Bohm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45. doi: 10.1016/S0140-6736(13)61783-3. Epub 2013 Sep 3.

  PMID: 24011548 BACKGROUND

• Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.

  PMID: 22920912 BACKGROUND

• Sleeper LA, Reynolds HR, White HD, Webb JG, Dzavik V, Hochman JS. A severity scoring system for risk assessment of patients with cardiogenic shock: a report from the SHOCK Trial and Registry. Am Heart J. 2010 Sep;160(3):443-50. doi: 10.1016/j.ahj.2010.06.024.

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• Katz JN, Stebbins AL, Alexander JH, Reynolds HR, Pieper KS, Ruzyllo W, Werdan K, Geppert A, Dzavik V, Van de Werf F, Hochman JS; TRIUMPH Investigators. Predictors of 30-day mortality in patients with refractory cardiogenic shock following acute myocardial infarction despite a patent infarct artery. Am Heart J. 2009 Oct;158(4):680-7. doi: 10.1016/j.ahj.2009.08.005.

  PMID: 19781431 BACKGROUND

• Thiele H, Ohman EM, Desch S, Eitel I, de Waha S. Management of cardiogenic shock. Eur Heart J. 2015 May 21;36(20):1223-30. doi: 10.1093/eurheartj/ehv051. Epub 2015 Mar 1.

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• De Backer D, Biston P, Devriendt J, Madl C, Chochrad D, Aldecoa C, Brasseur A, Defrance P, Gottignies P, Vincent JL; SOAP II Investigators. Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med. 2010 Mar 4;362(9):779-89. doi: 10.1056/NEJMoa0907118.

  PMID: 20200382 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

• Mebazaa A, Nieminen MS, Packer M, Cohen-Solal A, Kleber FX, Pocock SJ, Thakkar R, Padley RJ, Poder P, Kivikko M; SURVIVE Investigators. Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial. JAMA. 2007 May 2;297(17):1883-91. doi: 10.1001/jama.297.17.1883.

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• Felker GM, Benza RL, Chandler AB, Leimberger JD, Cuffe MS, Califf RM, Gheorghiade M, O'Connor CM; OPTIME-CHF Investigators. Heart failure etiology and response to milrinone in decompensated heart failure: results from the OPTIME-CHF study. J Am Coll Cardiol. 2003 Mar 19;41(6):997-1003. doi: 10.1016/s0735-1097(02)02968-6.

  PMID: 12651048 BACKGROUND

• Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901.

  PMID: 10460813 BACKGROUND

• Dzavik V, Sleeper LA, Cocke TP, Moscucci M, Saucedo J, Hosat S, Jiang X, Slater J, LeJemtel T, Hochman JS; SHOCK Investigators. Early revascularization is associated with improved survival in elderly patients with acute myocardial infarction complicated by cardiogenic shock: a report from the SHOCK Trial Registry. Eur Heart J. 2003 May;24(9):828-37. doi: 10.1016/s0195-668x(02)00844-8.

  PMID: 12727150 BACKGROUND

• Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

  PMID: 25173339 BACKGROUND

• O'Connor CM, Gattis WA, Uretsky BF, Adams KF Jr, McNulty SE, Grossman SH, McKenna WJ, Zannad F, Swedberg K, Gheorghiade M, Califf RM. Continuous intravenous dobutamine is associated with an increased risk of death in patients with advanced heart failure: insights from the Flolan International Randomized Survival Trial (FIRST). Am Heart J. 1999 Jul;138(1 Pt 1):78-86. doi: 10.1016/s0002-8703(99)70250-4.

  PMID: 10385768 BACKGROUND

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):1810-52. doi: 10.1161/CIR.0b013e31829e8807. Epub 2013 Jun 5. No abstract available.

  PMID: 23741057 BACKGROUND

• Delmas C, Puymirat E, Leurent G, Elbaz M, Manzo-Silberman S, Bonello L, Gerbaud E, Bataille V, Levy B, Lamblin N, Bonnefoy E, Henry P, Roubille F; FRENSHOCK investigators. Design and preliminary results of FRENSHOCK 2016: A prospective nationwide multicentre registry on cardiogenic shock. Arch Cardiovasc Dis. 2019 May;112(5):343-353. doi: 10.1016/j.acvd.2019.02.001. Epub 2019 Apr 11.

  PMID: 30982720 RESULT

• Cherbi M, Roubille F, Gerbaud E, Bonnefoy E, Lamblin N, Bonello L, Levy B, Lim P, Merdji H, Elbaz M, Khachab H, Bourenne J, Seronde MF, Schurtz G, Harbaoui B, Vanzetto G, Combaret N, Lattuca B, Leurent G, Puymirat E, Delmas C. Clinical profile, short and long-term outcomes of non-ischaemic cardiogenic shock: A FRENSHOCK sub-analysis. ESC Heart Fail. 2025 Jun;12(3):2335-2346. doi: 10.1002/ehf2.15046. Epub 2025 Mar 25.

  PMID: 40130820 DERIVED

• Volle K, Merdji H, Bataille V, Lamblin N, Roubille F, Levy B, Champion S, Lim P, Schneider F, Labbe V, Khachab H, Bourenne J, Seronde MF, Schurtz G, Harbaoui B, Vanzetto G, Quentin C, Combaret N, Marchandot B, Lattuca B, Biendel C, Leurent G, Bonello L, Gerbaud E, Puymirat E, Bonnefoy E, Aissaoui N, Delmas C; FRENSHOCK Investigator. Ventilation strategies in cardiogenic shock: insights from the FRENSHOCK observational registry. Clin Res Cardiol. 2025 Oct;114(10):1311-1323. doi: 10.1007/s00392-024-02551-x. Epub 2024 Oct 23.

  PMID: 39441346 DERIVED

• Roubille F, Cherbi M, Kalmanovich E, Delbaere Q, Bonnefoy-Cudraz E, Puymirat E, Schurtz G, Gerbaud E, Bonello L, Lim P, Leurent G, Roubille C, Delmas C. The admission level of CRP during cardiogenic shock is a strong independent risk marker of mortality. Sci Rep. 2024 Jul 16;14(1):16338. doi: 10.1038/s41598-024-67556-y.

  PMID: 39014136 DERIVED

• Manzo-Silberman S, Martin AC, Boissier F, Hauw-Berlemont C, Aissaoui N, Lamblin N, Roubille F, Bonnefoy E, Bonello L, Elbaz M, Schurtz G, Morel O, Leurent G, Levy B, Jouve B, Harbaoui B, Vanzetto G, Combaret N, Lattucca B, Champion S, Lim P, Bruel C, Schneider F, Seronde MF, Bataille V, Gerbaud E, Puymirat E, Delmas C; FRENSHOCK investigators. Sex disparities in cardiogenic shock: Insights from the FRENSHOCK registry. J Crit Care. 2024 Aug;82:154785. doi: 10.1016/j.jcrc.2024.154785. Epub 2024 Mar 16.

  PMID: 38493531 DERIVED

• Cherbi M, Bouisset F, Bonnefoy E, Lamblin N, Gerbaud E, Bonello L, Levy B, Lim P, Joffre J, Beuzelin M, Roland Y, Niquet L, Favory R, Khachab H, Harbaoui B, Vanzetto G, Combaret N, Marchandot B, Lattuca B, Leurent G, Lairez O, Puymirat E, Roubille F, Delmas C. Characteristics, management, and mid-term prognosis of older adults with cardiogenic shock admitted to intensive care units: Insights from the FRENSHOCK registry. Int J Cardiol. 2024 Jan 15;395:131578. doi: 10.1016/j.ijcard.2023.131578. Epub 2023 Nov 11.

  PMID: 37956759 DERIVED

• Cherbi M, Bonnefoy E, Lamblin N, Gerbaud E, Bonello L, Roubille F, Levy B, Champion S, Lim P, Schneider F, Elbaz M, Khachab H, Bourenne J, Seronde MF, Schurtz G, Harbaoui B, Vanzetto G, Combaret N, Labbe V, Marchandot B, Lattuca B, Biendel-Picquet C, Leurent G, Puymirat E, Maury P, Delmas C. One-year outcomes in cardiogenic shock triggered by supraventricular tachycardia: an analysis of the FRENSHOCK multicenter prospective registry. Front Cardiovasc Med. 2023 Sep 5;10:1167738. doi: 10.3389/fcvm.2023.1167738. eCollection 2023.

  PMID: 37731529 DERIVED

• Cherbi M, Roubille F, Lamblin N, Bonello L, Leurent G, Levy B, Elbaz M, Champion S, Lim P, Schneider F, Cariou A, Khachab H, Bourenne J, Seronde MF, Schurtz G, Harbaoui B, Vanzetto G, Quentin C, Delabranche X, Aissaoui N, Combaret N, Tomasevic D, Marchandot B, Lattuca B, Henry P, Gerbaud E, Bonnefoy E, Puymirat E, Maury P, Delmas C. One-year outcomes in cardiogenic shock triggered by ventricular arrhythmia: An analysis of the FRENSHOCK multicenter prospective registry. Front Cardiovasc Med. 2023 Jan 26;10:1092904. doi: 10.3389/fcvm.2023.1092904. eCollection 2023.

  PMID: 36776263 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Clément DELMAS

  AP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 9, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

FR (1)