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

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Treatments: Norepinephrine

Criteria

Inclusion Criteria:

1. Planned early revascularization by PCI (percutaneous coronary intervention)

2. a) Systolic blood pressure (SBP) <90 mmHg for > 30 minutes, OR b) Use of drugs to maintain SBP > 90 mmHg at presentation before randomization.

3. Signs of pulmonary congestion

4. 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

Exclusion Criteria:

• Resuscitation >30 minutes

• No intrinsic heart action

• Cerebral deficit with fixed dilated pupils (not drug-induced)

• Mechanical cause of cardiogenic shock

• Onset of shock >12 hours

• Massive lung embolism

• Shock due to other cause (bradycardia, sepsis, hypovolemia, etc.)