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Clinical Trials/EUCTR2021-005551-36-NL
EUCTR2021-005551-36-NL
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

Not provided0 sites776 target enrollmentApril 13, 2022
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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
Not provided
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
April 13, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Not provided

Eligibility Criteria

Inclusion Criteria

  • •1\. Acute myocardial infarction, STEMI or NSTEMI
  • •2\. 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

Outcomes

Primary Outcomes

Not specified

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