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

Phase 4

Recruiting

• Conditions: Cardiogenic Shock; Myocardial Infarction
• Interventions: Drug: Reduced noradrenaline use

• Registration Number: NCT05168462
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-23
• Study Start: 2022-10-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 776

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced noradrenaline (MAP ≥ 55 mmHg)	Reduced noradrenaline use	-

Primary Outcome Measures

Name	Time	Method
Mortality and renal failure	30-days	Composite of all-cause mortality and severe renal failure leading to renal replacement therapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Netherlands