NORSHOCK

• Research type

  Research Study

• Full title

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

• IRAS ID

  354410

• Contact name

  Alastair Proudfoot

• Contact email

  alastair.proudfoot1@nhs.net

• Sponsor organisation

  Amsterdam University Medical Center, AMC

• Clinicaltrials.gov Identifier

  NCT05168462

• Clinicaltrials.gov Identifier

  2021-005551-36, EudraCT number; 2024-510892-40-00, EU trial number

• Duration of Study in the UK

  1 years, 5 months, 31 days

• Research summary

  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 rates. The first line pharmacologic treatment strategy in CS is noradrenaline to maintain adequate blood pressure. The current guidelines have a weak recommendation for targeting a mean arterial blood pressure (MAP) of ≥ 65 mmHg in order to improve flow and thereby tissue perfusion of the myocardium, kidneys and other organs. However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to higher end-organ blood flow and better outcomes. The use of noradrenaline may compromise myocardial blood flow in this condition and thus lead to infarct size expansion and worse clinical outcome.
  Objective: With this study we aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP-target of ≥ 55 mmHg, compared to standard care (target-MAP usually ≥ 65 mmHg). We 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 use, by means of a lower MAP- target regimen ( ≥ 55 mmHg).
  Main study parameters/endpoints: Primary endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization. Secondary endpoints: duration of catecholamine therapy, enzymatic infarct size, hemodynamic parameters, length of stay in hospital and Intensive Care Unit, quality of life.
  Follow up: 30-days, 3-month, 6-month and 1-year after randomization. At follow-up information on organ function (blood test, echocardiography) will be gathered, if part of routine care. Additionally, patients will be asked to fill in a questionnaire at 30-days, 3-months, 6-months and 1-year

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  25/NW/0133

• Date of REC Opinion

  20 May 2025

• REC opinion

  Favourable Opinion