Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
Recruiting now · Phase 4
Conditions studied: Cardiogenic Shock, Myocardial Infarction
In brief
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.
Key facts
- Study ID
- NCT05168462
- Run by
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- People needed
- 776
- Starts
- 2022-10-01
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Amsterdam UMC, location AMC — Amsterdam, Netherlands (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.