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

Myocardial Infarction Clinical Trial

— NORSHOCK  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05168462
• Other study ID #: NL79416.018.21
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: February 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Elma Peters
• Phone: 0205668380
• Email: e.j.peters[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 776
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 to maintain SBP > 90 mmHg at randomization.

II. Clinical 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 III. Clinical signs of pulmonary congestion

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Hypotension
• Infarction
• Myocardial Infarction
• Shock
• Shock, Cardiogenic

Intervention

Drug:
• Reduced noradrenaline use
Reduced noradrenaline by using a lower MAP target

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality and renal failure	Composite of all-cause mortality and severe renal failure leading to renal replacement therapy	30-days
Secondary	Blood pressure (systolic and diastolic)	Blood pressure measured hourly during the first 24 hours of ICU/CCU admission	The first 24 hours
Secondary	Heart rate	Heart rate, measured hourly during the first 24 hours of ICU/CCU admission	The first 24 hours
Secondary	Enzymatic infarct size, measured by hs-Troponin T	Size of myocardial infarction, measured by hs-Troponin T	0, 6, 12, 24, 36 and 72 hours
Secondary	Enzymatic infarct size, measured by CK-MB	Size of myocardial infarction, measured by CK-MB	0, 6, 12, 24, 36 and 72 hours
Secondary	Need for mechanical circulatory support	Type of mechanical circulatory support device	Recorded after ICU/CCU discharge, assessed up to 60 days
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation, expressed in days	Recorded after ICU/CCU discharge, assessed up to 60 days
Secondary	Need for vasopressors / inotropes	The type of vasopressors / inotropes that were administrered	Recorded after ICU/CCU discharge, assessed up to 60 days
Secondary	Ejection fraction, percent	As measured by echocardiography and/or MRI	72 hours and 1 year
Secondary	Renal function	Renal function, measured by serum creatinin	1 year
Secondary	Cost-effectiveness	Cost per patients alive without severe renal failure and costs per QALY (quality-adjusted life year)	1-year