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NCT Number: NCT05168462

Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction

Rationale: Pump failure due to acute myocardial infarction (AMI) can lead to cardiogenic shock (CS): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. The first line pharmacologic treatment strategy in CS is noradrenaline. This vasopressor drug is used to maintain adequate blood pressures. The assumption is that a mean arterial blood pressure (MAP) ≥ 65 mmHg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes.

Objective: With this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP target of ≥ 55 mmHg, compared to ≥ 65 mmHg. The investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy.

Study design: Open label, randomized controlled multicenter trial

Study population: Adults patients with CS due to AMI

Intervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg).

Main study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amsterdam UMC, location AMC

Amsterdam, 1105AZ, Netherlands

Location status: Recruiting

Location contact

Jose Henriques

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 randomization.

II. Clinical signs of impaired organ perfusion with at least one of the following criteria:

  • Altered mental status
  • Cold, clammy skin and extremities
  • Oliguria with urine output < 30ml/hour
  • 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 (i.e. ECPR)
  • Women <45 years

Treatment and study plan

Reduced noradrenaline use

Drug

Reduced noradrenaline by using a lower MAP target

Primary outcomes

  1. Mortality and renal failure

    Time frame: 30-days

    Composite of all-cause mortality and severe renal failure leading to renal replacement therapy

Secondary outcomes

  1. Blood pressure (systolic and diastolic)

    Time frame: The first 24 hours

    Blood pressure measured hourly during the first 24 hours of ICU/CCU admission

  2. Heart rate

    Time frame: The first 24 hours

    Heart rate, measured hourly during the first 24 hours of ICU/CCU admission

  3. Enzymatic infarct size, measured by hs-Troponin T

    Time frame: 0, 6, 12, 24, 36 and 72 hours

    Size of myocardial infarction, measured by hs-Troponin T

  4. Enzymatic infarct size, measured by CK-MB

    Time frame: 0, 6, 12, 24, 36 and 72 hours

    Size of myocardial infarction, measured by CK-MB

  5. Need for mechanical circulatory support

    Time frame: Recorded after ICU/CCU discharge, assessed up to 60 days

    Type of mechanical circulatory support device

  6. Duration of mechanical ventilation

    Time frame: Recorded after ICU/CCU discharge, assessed up to 60 days

    Duration of mechanical ventilation, expressed in days

  7. Need for vasopressors / inotropes

    Time frame: Recorded after ICU/CCU discharge, assessed up to 60 days

    The type of vasopressors / inotropes that were administrered

  8. Ejection fraction, percent

    Time frame: 72 hours and 1 year

    As measured by echocardiography and/or MRI

  9. Renal function

    Time frame: 1 year

    Renal function, measured by serum creatinin

  10. Cost-effectiveness

    Time frame: 1-year

    Cost per patients alive without severe renal failure and costs per QALY (quality-adjusted life year)

Study contacts

Contact information is provided by the study sponsor or research team.

Elma Peters

CONTACT

[email protected]

0205668380

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Acronym: NORSHOCK

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Dec 23, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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