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o RESEARCH QUESTION

What is the (cost-)effectiveness of a treatment strategy of reduced noradrenaline by using a lower blood pressure target in patients with cardiogenic shock (CS) from acute myocardial infarction (AMI)?

 

o HYPOTHESIS

A treatment strategy of reduced noradrenaline use will increase organ perfusion and decrease adverse events. This will decrease the risk of organ failure and subsequent hospital admissions, organ replacement therapy and mortality. We anticipate a considerable reduction in healthcare costs. Furthermore, information on the efficacy and effectiveness of this routinely used drug will result in better understanding of current therapy and initiate development of evidence-based guideline recommendations.

 

o STUDY DESIGN

An open label, multicenter randomized controlled trial to ensure level 1 evidence for superiority of the intervention. The usual care arm will provide a reliable basis for the cost-effectiveness analysis. Patients will be randomly assigned (1:1 ratio).

 

o STUDY POPULATION

Consecutive patients with CS after AMI.

 

o INTERVENTION

Treatment strategy of reduced noradrenaline, by using a lower MAP target (=55mmHg).

 

o OUTCOME MEASURES

• Clinical primary end-point: composite of all-cause mortality and severe renal failure within 30-days after randomization.

 

• Cost-effectiveness primary end-point: costs per quality adjusted life year (QALY)

 

o SAMPLE SIZE/DATA-ANALYSIS

782 patients, per patientanalysis for primary outcome; incremental cost-utility ratio analysis.

 

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