Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced noradrenaline (MAP ≥ 55 mmHg) | Experimental |
| |
| Usual care (MAP ≥ 65 mmHg) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced noradrenaline use | Drug | Reduced noradrenaline by using a lower MAP target |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality and renal failure | Composite of all-cause mortality and severe renal failure leading to renal replacement therapy | 30-days |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure (systolic and diastolic) | Blood pressure measured hourly during the first 24 hours of ICU/CCU admission | The first 24 hours |
| Heart rate | Heart rate, measured hourly during the first 24 hours of ICU/CCU admission |
Not provided
Inclusion criteria:
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:
III. Clinical signs of pulmonary congestion
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elma Peters | Contact | 0205668380 | e.j.peters@amsterdamumc.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, location AMC | Recruiting | Amsterdam | 1105AZ | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| The first 24 hours |
| 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 |
| Enzymatic infarct size, measured by CK-MB | Size of myocardial infarction, measured by CK-MB | 0, 6, 12, 24, 36 and 72 hours |
| Need for mechanical circulatory support | Type of mechanical circulatory support device | Recorded after ICU/CCU discharge, assessed up to 60 days |
| Duration of mechanical ventilation | Duration of mechanical ventilation, expressed in days | Recorded after ICU/CCU discharge, assessed up to 60 days |
| Need for vasopressors / inotropes | The type of vasopressors / inotropes that were administrered | Recorded after ICU/CCU discharge, assessed up to 60 days |
| Ejection fraction, percent | As measured by echocardiography and/or MRI | 72 hours and 1 year |
| Renal function | Renal function, measured by serum creatinin | 1 year |
| Cost-effectiveness | Cost per patients alive without severe renal failure and costs per QALY (quality-adjusted life year) | 1-year |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
Not provided
Not provided