Background
In acute myocardial infarction (AMI) complicated by cardiogenic shock (CS), noradrenaline is considered the first-line vasopressor of choice to achieve hemodynamic stabilization. However, noradrenaline is also associated with decreased myocardial perfusion and increased afterload leading to infarct size expansion. Also, achieving a target mean arterial pressure (MAP) of more than 65 mmHg is based on settings of sepsis, the optimal MAP in CS patients remains a knowledge deficit. Therefore, a prospective randomized clinical trial investigating the clinical outcomes of reduced noradrenaline is needed.
Study design
The NORSHOCK trial is an open label, randomized, international multicenter trial in which we aim to include 776 patients presenting with CS after AMI. It is designed to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP-target of 55 mmHg, compared to standard care (target-MAP usually ≥ 65 mmHg). Patients will be randomized to one of both treatment arms. The primary composite endpoint consists of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization. Secondary outcomes include duration of catecholamine therapy, enzymatic infarct size, hemodynamic parameters and length of stay in hospital and Intensive Care Units (ICU).
Conclusions
The NORSHOCK study will address important questions regarding the frequent use of noradrenaline in excessive doses in cardiogenic shock patients after acute myocardial infarction.