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
Introduction
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.
Objective
With this study we aim 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). We hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy.
Study design
Open label, randomized controlled international multicenter trial.
Study population
Adults patients presenting with cardiogenic shock after myocardial infarction in which we aim to include 776 patients presenting with CS after AMI.
Main study endpoints
Primary endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.
Secondary endpoints: duration of catecholamine therapy, enzymatic infarct size, hemodynamic parameters, length of stay in hospital and Intensive Care Units (ICU), quality of life (QOL).
Contact
Sanne ten Berg / Elma Peters
norshock@amsterdamumc.nl
Phone
020-566 8380
