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

Phase 1

Conditions: Acute myocardial infarction complicated by cardiogenic shock
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: CTIS2024-510892-40-00

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 776

Inclusion Criteria

Acute myocardial infarction, STEMI or NSTEMI, Early revascularization by PCI, Cardiogenic shock, characterized by: I. a. Systolic blood pressure (SBP) < 90 mmHg for > 30 minutes, OR b. Use of drugs to maintain SBP > 90 mmHg at presentation before randomization. II. Clinical signs of impaired organ perfusion with at least one of the following criteria: a. Altered mental status b. Cold, clammy skin and extremities c. Oliguria with urine output < 30ml/hour d. Serum lactate > 2.0 mmol/L III. Clinical signs of pulmonary congestion

Exclusion Criteria

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, Women < 45 years

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to test whether a treatment strategy with reduced use of noradrenaline in patients with cardiogenic shock is superior to standard care in terms of combined all-cause mortality and renal failure at 30 days.;Secondary Objective: Does a treatment strategy with reduced use of noradrenaline in patients with cardiogenic shock lead to lower all-cause mortality at 30 days?, Does a treatment strategy with reduced use of noradrenaline in patients with cardiogenic shock lead to reduced cardiovascular death at 30 days?, Does a treatment strategy with reduced use of noradrenaline in patients with cardiogenic shock lead to an increase of days alive and out of hospital at 30 days?;Primary end point(s): The primary endpoint of the study is the composite of all-cause mortality and severe renal failure requiring renal replacement therapy within 30 days after randomization.

Secondary Outcome Measures