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Clinical Trials/EUCTR2021-005551-36-DK
EUCTR2021-005551-36-DK
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: A Multicenter Randomized Trial - NORSHOCK

Amsterdam University Medical Center, AMC0 sites776 target enrollmentFebruary 28, 2023
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ConditionsMyocardial infarction related cardiogenic shockTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsNorepinephrine

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Myocardial infarction related cardiogenic shock
Sponsor
Amsterdam University Medical Center, AMC
Enrollment
776
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 28, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Amsterdam University Medical Center, AMC

Eligibility 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 \< 30ml/hour
  • •d. Serum lactate \> 2\.0 mmol/L
  • •II. a. Systolic blood pressure (SBP) \< 90 mmHg for \> 30 minutes, OR
  • •b. Use of drugs to maintain SBP \> 90 mmHg at presentation before randomization.

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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