[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452204":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":23,"locations":29,"responsibleParty":47,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Reduced noradrenaline (MAP ≥ 55 mmHg)","EXPERIMENTAL",null,[13],"Drug: Reduced noradrenaline use",{"label":15,"type":16,"description":11,"interventionNames":11},"Usual care (MAP ≥ 65 mmHg)","NO_INTERVENTION",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Reduced noradrenaline use","Reduced noradrenaline by using a lower MAP target",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Elma Peters","CONTACT","0205668380","e.j.peters@amsterdamumc.nl",[30],{"facility":31,"status":32,"city":33,"state":11,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Amsterdam UMC, location AMC","RECRUITING","Amsterdam","1105AZ","Netherlands","NL",{"type":38,"coordinates":39},"Point",[40,41],4.88969,52.37403,{"lat":41,"lon":40},[44],{"name":45,"role":26,"phone":11,"phoneExt":11,"email":46},"Jose Henriques","j.p.henriques@amsterdamumc.nl",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","J.P.S Henriques","Prof. dr.","100452204","phase-4-clinical-outcome-and-cost-effectiveness-of-reduced-noradrenaline-by-using-a-lower-blood-pressure-target-in-patients-with-cardiogenic-shock-from-acute-myocardial-infarction-100452204",false,"NCT05168462","Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction","NORSHOCK","Inclusion criteria:\n\n1. Acute myocardial infarction, STEMI or NSTEMI\n2. Early revascularization by PCI\n3. Cardiogenic shock, characterized by:\n\nI. a. Systolic blood pressure (SBP) ≤ 90 mmHg for \\> 30 minutes, OR b. Use of drugs to maintain SBP \\> 90 mmHg at randomization.\n\nII. Clinical signs of impaired organ perfusion with at least one of the following criteria:\n\n1. Altered mental status\n2. Cold, clammy skin and extremities\n3. Oliguria with urine output \\\u003C 30ml\u002Fhour\n4. Serum lactate \\> 2.0 mmol\u002FL\n\nIII. Clinical signs of pulmonary congestion\n\nExclusion Criteria:\n\n1. Resuscitation \\> 30 minutes\n2. Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)\n3. Onset of shock \\> 12 hours\n4. Imminent need for mechanical circulatory support (i.e. ECPR)\n5. Women \\\u003C45 years","ALL","18 Years",{"count":61,"type":62},776,"ESTIMATED","INTERVENTIONAL",[65],"PHASE4","Rationale: Pump failure due to acute myocardial infarction (AMI) can lead to cardiogenic shock (CS): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. The first line pharmacologic treatment strategy in CS is noradrenaline. This vasopressor drug is used to maintain adequate blood pressures. The assumption is that a mean arterial blood pressure (MAP) ≥ 65 mmHg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes.\n\nObjective: With this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP target of ≥ 55 mmHg, compared to ≥ 65 mmHg. The investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy.\n\nStudy design: Open label, randomized controlled multicenter trial\n\nStudy population: Adults patients with CS due to AMI\n\nIntervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg).\n\nMain study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.",[68,69],"Cardiogenic Shock","Myocardial Infarction",[71,72,73,74],"Noradrenaline","Blood pressure target","Cardiogenic shock","Myocardial infarction","2026-03-24",{"date":77,"type":78},"2026-03-27","ACTUAL",{"date":80,"type":78},"2022-10-01",{"date":82,"type":62},"2028-04-01",{"name":5,"class":6},1]