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.
Objective: 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.
Study design: Open label, randomized controlled multicenter trial
Study population: Adults patients with CS due to AMI
Intervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg).
Main study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.
Acute myocardial infarction, STEMI or NSTEMI
Early revascularization by PCI
Altered mental status
Cold, clammy skin and extremities
Resuscitation > 30 minutes
Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)
Onset of shock > 12 hours
Imminent need for mechanical circulatory support (i.e. ECPR)
Parallel
Reduced noradrenaline use
DrugReduced noradrenaline by using a lower MAP target
Mortality and renal failure
Composite of all-cause mortality and severe renal failure leading to renal replacement therapy
Blood pressure (systolic and diastolic)
Blood pressure measured hourly during the first 24 hours of ICU/CCU admission
Heart rate
Heart rate, measured hourly during the first 24 hours of ICU/CCU admission
Enzymatic infarct size, measured by hs-Troponin T
Size of myocardial infarction, measured by hs-Troponin T
Enzymatic infarct size, measured by CK-MB
Size of myocardial infarction, measured by CK-MB
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