Outcomes for people with cardiogenic shock after myocardial infarction by comparing two blood pressure targets.

Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients with Cardiogenic Shock from Acute Myocardial Infarction: A Multicenter Randomized Trial - NORSHOCK

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005551-36-DK

Enrollment

776

Registered

2023-02-28

Start date

2023-05-01

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial infarction related cardiogenic shock

Interventions

Trade Name: Norepinephrine Pharmaceutical Form: INN or Proposed INN: Norepinephrine CAS Number: 51-41-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Acute myocardial infarction, STEMI or NSTEMI 2. Early revascularization by PCI 3. Cardiogenic shock, characterized by: I. 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 2.0 mmol/L II. a. Systolic blood pressure (SBP) 30 minutes, OR b. Use of drugs to maintain SBP > 90 mmHg at presentation before randomization. III. Clinical signs of pulmonary congestion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 276 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether outcomes for patients with cardiogenic shock is better (in terms of survival and renal functioning) when less norepinephrine is administered. ;Secondary Objective: To evaluate cost-effectiveness. ;Primary end point(s): The composite of all-cause mortality and severe renal failure requiring renal replacement therapy within 30 days after randomization.;Timepoint(s) of evaluation of this end point: 30 days after randomization	—

Measure

Time frame

Main Objective: To investigate whether outcomes for patients with cardiogenic shock is better (in terms of survival and renal functioning) when less norepinephrine is administered. ;Secondary Objective: To evaluate cost-effectiveness. ;Primary end point(s): The composite of all-cause mortality and severe renal failure requiring renal replacement therapy within 30 days after randomization.;Timepoint(s) of evaluation of this end point: 30 days after randomization

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Secondary

Measure	Time frame
Secondary end point(s): All-cause mortality at 30 days Days alive and out of hospital (30 days) Days alive and out of ICU (30 days) Cardiovascular death at 1 year Enzymatic infarct size Lactate clearance (mean + area under the curve 0-36 hours) Days alive and free of mechanical ventilation (30 days) Days alive and free of mechanical circulatory support (30 days) Severe renal failure requiring renal replacement therapy (at 30 days, 1 year) Renal function (during hospital stay and 1 year) Time to peak creatinine (hospital stay) Time to renal replacement therapy Days alive and free of catecholamine therapy (30 days) Vasoactive inotropic score (VIS) (during hospital stay) Time to hemodynamic stabilization (hospital stay) Blood pressure and heart rate during the first 24 hours Hemodynamic parameters (during ICU / CCU admission) Arrhythmias during hospital admission Major vascular complication during hospital admission Infection / sepsis during hospital admission Myocardial re-infarction within 30 days Left ventricular ejection fraction (at day 3, before hospital discharge, and at 1 year) Neurological outcome (at 30 days and 1 year) Protocol adherence / use of bail-out therapy Hospital readmission for cardiac reason within 1 year;Timepoint(s) of evaluation of this end point: 30 days, 1 year	—

Measure

Time frame

Secondary end point(s): All-cause mortality at 30 days Days alive and out of hospital (30 days) Days alive and out of ICU (30 days) Cardiovascular death at 1 year Enzymatic infarct size Lactate clearance (mean + area under the curve 0-36 hours) Days alive and free of mechanical ventilation (30 days) Days alive and free of mechanical circulatory support (30 days) Severe renal failure requiring renal replacement therapy (at 30 days, 1 year) Renal function (during hospital stay and 1 year) Time to peak creatinine (hospital stay) Time to renal replacement therapy Days alive and free of catecholamine therapy (30 days) Vasoactive inotropic score (VIS) (during hospital stay) Time to hemodynamic stabilization (hospital stay) Blood pressure and heart rate during the first 24 hours Hemodynamic parameters (during ICU / CCU admission) Arrhythmias during hospital admission Major vascular complication during hospital admission Infection / sepsis during hospital admission Myocardial re-infarction within 30 days Left ventricular ejection fraction (at day 3, before hospital discharge, and at 1 year) Neurological outcome (at 30 days and 1 year) Protocol adherence / use of bail-out therapy Hospital readmission for cardiac reason within 1 year;Timepoint(s) of evaluation of this end point: 30 days, 1 year

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Countries

Denmark

Contacts

Public ContactProf Henriques

AMC

j.p.henriques@amsterdamumc.nl+31205669111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026