Clinical trial NCT05168462: Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cardiogenic Shock
Myocardial Infarction
Keywords: Noradrenaline
Blood pressure target
Cardiogenic shock
Myocardial infarction
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality and renal failure
timeFrame: 30-days
Secondary outcomes:
measure: Blood pressure (systolic and diastolic)
timeFrame: The first 24 hours
measure: Heart rate
timeFrame: The first 24 hours
measure: Enzymatic infarct size, measured by hs-Troponin T
timeFrame: 0, 6, 12, 24, 36 and 72 hours
measure: Enzymatic infarct size, measured by CK-MB
timeFrame: 0, 6, 12, 24, 36 and 72 hours
measure: Need for mechanical circulatory support
timeFrame: Recorded after ICU/CCU discharge, assessed up to 60 days
measure: Duration of mechanical ventilation
timeFrame: Recorded after ICU/CCU discharge, assessed up to 60 days
measure: Need for vasopressors / inotropes
timeFrame: Recorded after ICU/CCU discharge, assessed up to 60 days
measure: Ejection fraction, percent
timeFrame: 72 hours and 1 year
measure: Renal function
timeFrame: 1 year
measure: Cost-effectiveness
timeFrame: 1-year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
Study officials:
References: