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)

March 24, 2026 updated by: J.P.S Henriques, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

776

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Acute myocardial infarction, STEMI or NSTEMI
  2. Early revascularization by PCI
  3. 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:

  1. Altered mental status
  2. Cold, clammy skin and extremities
  3. Oliguria with urine output < 30ml/hour
  4. Serum lactate > 2.0 mmol/L

III. Clinical signs of pulmonary congestion

Exclusion Criteria:

  1. Resuscitation > 30 minutes
  2. Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)
  3. Onset of shock > 12 hours
  4. Imminent need for mechanical circulatory support (i.e. ECPR)
  5. Women <45 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reduced noradrenaline (MAP ≥ 55 mmHg)
Drug: Reduced noradrenaline use
Reduced noradrenaline by using a lower MAP target
No Intervention: Usual care (MAP ≥ 65 mmHg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality and renal failure
Time Frame: 30-days
Composite of all-cause mortality and severe renal failure leading to renal replacement therapy
30-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure (systolic and diastolic)
Time Frame: The first 24 hours
Blood pressure measured hourly during the first 24 hours of ICU/CCU admission
The first 24 hours
Heart rate
Time Frame: The first 24 hours
Heart rate, measured hourly during the first 24 hours of ICU/CCU admission
The first 24 hours
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
0, 6, 12, 24, 36 and 72 hours
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
0, 6, 12, 24, 36 and 72 hours
Need for mechanical circulatory support
Time Frame: Recorded after ICU/CCU discharge, assessed up to 60 days
Type of mechanical circulatory support device
Recorded after ICU/CCU discharge, assessed up to 60 days
Duration of mechanical ventilation
Time Frame: Recorded after ICU/CCU discharge, assessed up to 60 days
Duration of mechanical ventilation, expressed in days
Recorded after ICU/CCU discharge, assessed up to 60 days
Need for vasopressors / inotropes
Time Frame: Recorded after ICU/CCU discharge, assessed up to 60 days
The type of vasopressors / inotropes that were administrered
Recorded after ICU/CCU discharge, assessed up to 60 days
Ejection fraction, percent
Time Frame: 72 hours and 1 year
As measured by echocardiography and/or MRI
72 hours and 1 year
Renal function
Time Frame: 1 year
Renal function, measured by serum creatinin
1 year
Cost-effectiveness
Time Frame: 1-year
Cost per patients alive without severe renal failure and costs per QALY (quality-adjusted life year)
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL79416.018.21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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