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Clinical Trials/CTIS2024-510892-40-00
CTIS2024-510892-40-00
Active, not recruiting
Phase 1

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

Amsterdam UMC0 sites776 target enrollmentJanuary 16, 2024

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Acute myocardial infarction complicated by cardiogenic shock
Sponsor
Amsterdam UMC
Enrollment
776
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 16, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Amsterdam UMC

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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