[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659716":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":20,"studyPopulation":75,"armGroups":76,"interventions":20,"overallOfficials":80,"centralContacts":85,"locations":93,"responsibleParty":118,"collaborators":20,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":20,"enrollmentInfo":130,"targetDuration":20,"studyType":133,"phases":20,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":141,"whyStopped":20,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"French Cardiology Society","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"All-cause mortality during hospitalization and at 30 days","All-cause mortality assessed during the index hospitalization and at 30-day follow-up among patients hospitalized with cardiogenic shock of any etiology, excluding post-cardiotomy cardiogenic shock.","30 days",[14,18,22,25,28,31,33,36,39,42,44,46,49,52,54,58,62,65,68],{"measure":15,"description":16,"timeFrame":17},"Use of in-hospital organ support therapies","Number and percentage of patients who received renal replacement therapy (dialysis), invasive or non-invasive mechanical ventilation, or acute circulatory support (ECMO, Impella, IABP, or other mechanical circulatory support devices) during the index hospitalization.","Baseline",{"measure":19,"description":20,"timeFrame":21},"Cognitive impairment assessed by the Codex test",null,"Within 24 hours prior to hospital discharge",{"measure":23,"description":20,"timeFrame":24},"Use of long-term treatment for chronic heart failure among hospital discharge survivors","Within 24 hours prior to hospital discharge, 1 year, and 5 years",{"measure":26,"description":20,"timeFrame":27},"albumin-to-creatinine ratio","on admission, Within 24 hours prior to hospital discharge, and at 1 year",{"measure":29,"description":20,"timeFrame":30},"NYHA grade","1 year",{"measure":32,"description":20,"timeFrame":30},"FEVG",{"measure":34,"description":20,"timeFrame":35},"Number and percentage of patients receiving home hospitalization or admitted to a rehabilitation or palliative care unit","From index hospitalization through 5 years of follow-up",{"measure":37,"description":38,"timeFrame":35},"Number and percentage of patients followed by a cardiologist and frequency of follow-up","Number and percentage of patients receiving cardiology follow-up and frequency of follow-up visits in the immediate period after the index hospitalization and throughout the 5-year follow-up period.",{"measure":40,"description":41,"timeFrame":35},"Number and percentage of patients undergoing transthoracic echocardiography and frequency of examinations","Number and percentage of patients who underwent transthoracic echocardiography, and frequency of examinations, in the immediate period after the index hospitalization and throughout follow-up.",{"measure":43,"description":20,"timeFrame":35},"Number and percentage of patients receiving a LifeWest, pacemaker, cardiac resynchronization therapy device, or implantable cardioverter-defibrillator",{"measure":45,"description":20,"timeFrame":35},"Number and percentage of patients undergoing catheter ablation for atrial fibrillation\u002Fflutter and\u002For ventricular tachycardia\u002Ffibrillation",{"measure":47,"description":48,"timeFrame":35},"Number and percentage of patients followed by a nephrologist and frequency of follow-up","Number and percentage of patients receiving nephrology follow-up and frequency of follow-up visits in the immediate period after the index hospitalization and throughout the 5-year follow-up period.",{"measure":50,"description":51,"timeFrame":35},"Number and percentage of patients receiving chronic hemodialysis and type of hemodialysis","Number and percentage of patients who underwent one or more chronic hemodialysis sessions, and type of hemodialysis received, in the immediate period after the index hospitalization and throughout follow-up.",{"measure":53,"description":20,"timeFrame":35},"Number and percentage of hospital discharge survivors receiving chronic dialysis",{"measure":55,"description":56,"timeFrame":57},"Number and percentage of patients receiving durable mechanical circulatory support (LVAD, BiVAD, or TAH) or undergoing heart transplantation","Number and percentage of patients receiving durable mechanical circulatory support (left ventricular assist device \\[LVAD\\], biventricular assist device \\[BiVAD\\], or total artificial heart \\[TAH\\]) or undergoing heart transplantation.","30 days, 1 year, 5 years",{"measure":59,"description":60,"timeFrame":61},"Number and percentage of hospital discharge survivors rehospitalized for heart failure","Number and percentage of hospital discharge survivors with at least one rehospitalization for heart failure during follow-up.","1 year, 5 years",{"measure":63,"description":20,"timeFrame":64},"All-cause and cardiovascular mortality at 30 days, 1 year and 5 years","30 days, 1 year and 5 years",{"measure":66,"description":67,"timeFrame":17},"Socioeconomic deprivation assessed by FDep indices","Socioeconomic deprivation assessed using the French Deprivation Index (FDep) derived from INSEE territorial units (municipalities and IRIS areas).",{"measure":69,"description":70,"timeFrame":71},"Socioeconomic deprivation assessed by F-EDI indices","Socioeconomic deprivation assessed using the French European Deprivation Index (F-EDI) derived from INSEE territorial units (municipalities and IRIS areas).","baseline",{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":73,"timePerspective":74,"maskingInfo":20},"COHORT","PROSPECTIVE","Adult or pediatric patients presenting with cardiogenic shock",[77],{"label":78,"type":20,"description":79,"interventionNames":20},"Patients hospitalized with cardiogenic shock","Consecutive adult and pediatric patients hospitalized with cardiogenic shock of any etiology and enrolled during the index hospitalization.",[81],{"name":82,"affiliation":83,"role":84},"Clément DELMAS, MD","Hôpital Rangueil","PRINCIPAL_INVESTIGATOR",[86,91],{"name":82,"role":87,"phone":88,"phoneExt":89,"email":90},"CONTACT","01 44 90 70 28","+33","frenshock2@sfardio.fr",{"name":92,"role":87,"phone":88,"phoneExt":89,"email":90},"Hamid MERDJI, MD",[94,108],{"facility":95,"status":20,"city":96,"state":20,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"CHU Nouvel Hôpital Civil","Strasbourg","67000","France","FR",{"type":101,"coordinates":102},"Point",[103,104],7.74553,48.58392,{"lat":104,"lon":103},[107],{"name":92,"role":87,"phone":88,"phoneExt":89,"email":90},{"facility":83,"status":20,"city":109,"state":20,"zip":110,"country":98,"countryCode":99,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Toulouse","31400",{"type":101,"coordinates":112},[113,114],1.44367,43.60426,{"lat":114,"lon":113},[117],{"name":82,"role":87,"phone":88,"phoneExt":89,"email":90},{"type":119,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100659716","french-observatory-on-the-management-of-cardiogenic-shock-2-100659716",false,"NCT07868757","French Observatory on the Management of Cardiogenic Shock 2","French Observatory on the Management of Cardiogenic Shock 2 (FRENSHOCK 2)","FRENSHOCK 2","Adult Inclusion Criteria:\n\n* Patients covered by a national health insurance scheme.\n* Patients who have provided explicit consent for the use of their National Health Identifier (NIR) for research purposes. If obtaining consent is temporarily impossible due to the patient's clinical condition, the emergency consent procedure described in the protocol will be applied.\n* Patients meeting the FRENSHOCK definition of cardiogenic shock, with at least one positive criterion in each of the three categories below:\n\n  1. Low cardiac output, defined by at least one of the following:\n\n     * Clinical: systolic blood pressure (SBP) \\\u003C 90 mmHg and\u002For requirement for inotropic or vasopressor support to maintain SBP \\> 90 mmHg\n     * Echocardiography: cardiac index (CI) \\\u003C 2.2 L\u002Fmin\u002Fm²\n     * Hemodynamic assessment using a Swan-Ganz catheter or right heart catheterization: CI \\\u003C 2.2 L\u002Fmin\u002Fm²\n  2. Elevated pulmonary filling pressures\u002Fcongestion and\u002For elevated right-sided filling pressures, defined by at least one of the following:\n\n     * Clinical: left-sided and\u002For right-sided heart failure\n     * Imaging: signs of congestion on chest X-ray or chest CT scan, or diffuse bilateral B-lines on lung ultrasound\n     * Echocardiography: elevated left and\u002For right ventricular filling pressures according to current guideline recommendations\n     * Right heart catheterization or Swan-Ganz catheterization: pulmonary capillary wedge pressure \\> 15 mmHg and\u002For right atrial pressure \\> 8 mmHg\n  3. End-organ hypoperfusion, defined by at least one of the following:\n\n     * Clinical: new-onset oliguria \\\u003C 0.5 mL\u002Fkg\u002Fh, mottling, altered mental status, or capillary refill time \\> 3 seconds\n     * Laboratory findings: arterial lactate \\> 2 mmol\u002FL and\u002For ScvO2\u002FSvO2 \\\u003C 60% and\u002For veno-arterial CO2 gap \\> 6 mmHg\n\nPediatric inclusion criteria :\n\nChildren must meet a revised and age-adapted FRENSHOCK definition of cardiogenic shock as described below, taking into account age- and\u002For weight-specific normal values (blood pressure, cardiac output, and urine output).\n\n* Parent(s) or legal guardian(s) having provided explicit consent for the use of the child's National Health Identifier (NIR) for research purposes. The child will receive information appropriate to their age and level of understanding.\n* Patients covered by a national health insurance scheme.\n* Patients with cardiogenic shock, defined as meeting at least one positive criterion in each of the following three categories:\n\n  1. Low cardiac output, defined by at least one of the following:\n\n     * Clinical: systolic blood pressure below the 5th percentile for age and height and\u002For requirement for inotropic or vasopressor support\n     * Echocardiography: cardiac index \\\u003C 2.2 L\u002Fmin\u002Fm² or left ventricular ejection fraction (LVEF) \\\u003C 50%\n  2. Elevated pulmonary filling pressures\u002Fleft-sided congestion and\u002For elevated right-sided filling pressures, defined by at least one of the following:\n\n     * Clinical: left-sided and\u002For right-sided heart failure\n     * Imaging: pulmonary congestion on chest radiography or chest CT scan, or diffuse bilateral B-lines on lung ultrasound\n     * Echocardiography: elevated right- and\u002For left-sided filling pressures according to current guideline recommendations\n  3. End-organ hypoperfusion, defined by at least one of the following:\n\n     * Clinical: new-onset oliguria, defined as urine output \\\u003C 1 mL\u002Fkg\u002Fh in children younger than 2 years and \\\u003C 0.5 mL\u002Fkg\u002Fh in children aged 2 years or older, mottling, altered mental status, or capillary refill time \\> 3 seconds\n     * Laboratory findings: arterial lactate \\> 2 mmol\u002FL and\u002For ScvO2\u002FSvO2 \\\u003C 60% and\u002For veno-arterial CO2 gap \\> 6 mmHg\n\nAdult exclusion criteria :\n\n* Final diagnosis other than cardiogenic shock.\n* Unwitnessed and\u002For prolonged cardiac arrest (estimated low-flow duration \\> 30 minutes) and\u002For absence of return of spontaneous circulation at the time of hospital admission.\n* Post-cardiotomy cardiogenic shock.\n* Individuals deprived of liberty by judicial or administrative decision.\n* Adults under legal protection.\n* Refusal to participate or failure to implement the emergency inclusion procedure when required.\n\nPediatric exclusion criteria :\n\n* Preterm neonates (\\\u003C 37 weeks corrected gestational age).\n* Neonates diagnosed with cardiogenic shock at birth, with the exception of fetal or neonatal arrhythmias.\n* Neonates with right-sided cardiogenic shock secondary to persistent pulmonary hypertension of the newborn.\n* Final diagnosis other than cardiogenic shock.\n* Unwitnessed and\u002For prolonged cardiac arrest (estimated low-flow duration \\> 30 minutes) and\u002For absence of return of spontaneous circulation at the time of hospital admission.\n* Cardiac arrest of non-cardiac origin.\n* Post-cardiotomy cardiogenic shock.\n* Patients not covered by a national health insurance scheme.\n* Refusal of participation by the parent(s) or legal guardian(s), or failure to implement the emergency inclusion procedure when required.","ALL","0 Days",{"count":131,"type":132},1000,"ESTIMATED","OBSERVATIONAL","The aim of this observational study is to describe the baseline characteristics, management strategies, and early outcomes (during hospitalisation and at 30 days) of patients admitted to intensive care with cardiogenic shock, regardless of aetiology.\n\nThis prospective multicenter registry will enroll consecutive patients admitted to participating adult and pediatric critical care units in France, using current definitions and classifications of cardiogenic shock. The study aims to improve patient characterization and risk stratification and support the development of future interventional studies. 1,000 patients will be enrolled over 12 months, with follow-up at 30 days, 1 year, and through linkage with the French National Health Data System (SNDS) at 1 and 5 years.",[136],"Cardiogenic Shock",[138,139,140],"heart disease","shock","Cardiogenic shock","NOT_YET_RECRUITING","2026-10-07",{"date":144,"type":145},"2026-10-09","ACTUAL",{"date":147,"type":132},"2027-01",{"date":149,"type":132},"2033-01",{"name":5,"class":6},2]