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Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction

RecruitingPhase 4Ages 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Amsโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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) โ‰ฅ 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 โ‰ฅ 55 mmHg, compared to โ‰ฅ 65 mmHg. The investigators hypothesize

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: 1. Acute myocardial infarction, STEMI or NSTEMI 2. Early revascularization by PCI 3. Cardiogenic shock, characterized by: I. a. Systolic blood pressure (SBP) โ‰ค 90 mmHg for \> 30 minutes, OR b. Use of drugs to maintain SBP \> 90 mmHg at randomization. II. Clinical signs of impaired organ perfusion with at least one of the following criteria: 1. Altered mental status 2. Cold, clammy skin and extremities 3. Oliguria with urine output \< 30ml/hour 4. Serum lactate \> 2.0 mmol/L III. Clinical signs of pulmonary congestion Exclusion Criteria: 1. Resuscitation \> 30 minutes 2. Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture) 3. Onset of shock \> 12 hours 4. Imminent need for mechanical circulatory support (i.e. ECPR) 5. Women \<45 years
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What it tests

  • Reduced noradrenaline use
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Where

1 site
Amsterdam UMC, location AMC
Amsterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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