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

Last updated: February 23, 2023
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

4

Condition

Heart Disease

Dizzy/fainting Spells

Heart Defect

Treatment

N/A

Clinical Study ID

NCT05168462
NL79416.018.21
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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 tomaintain SBP > 90 mmHg at randomization. II. Clinical signs of impaired organ perfusion with at least one of the following criteria:
  4. Altered mental status
  5. Cold, clammy skin and extremities
  6. Oliguria with urine output < 30ml/hour
  7. Serum lactate > 2.0 mmol/L III. Clinical signs of pulmonary congestion

Exclusion

Exclusion Criteria:

  1. Resuscitation > 30 minutes
  2. Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricularseptal rupture)
  3. Onset of shock > 12 hours
  4. Imminent need for mechanical circulatory support

Study Design

Total Participants: 776
Study Start date:
October 01, 2022
Estimated Completion Date:
June 01, 2026

Connect with a study center

  • Amsterdam UMC, location AMC

    Amsterdam, 1105AZ
    Netherlands

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.