Outcomes for people with cardiogenic shock after myocardial infarction by comparing two blood pressure targets.
- Conditions
- Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Myocardial infarction related cardiogenic shock
- Registration Number
- EUCTR2021-005551-36-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 776
1. Acute myocardial infarction, STEMI or NSTEMI
2. Cardiogenic shock, characterized by:
I. Signs of impaired organ perfusion with at least one of the following criteria:
a. Altered mental status
b. Cold, clammy skin and extremities
c. Oliguria with urine output < 30ml/hour
d. Serum lactate > 2.0 mmol/L
II. a. Systolic blood pressure (SBP) < 90 mmHg for > 30 minutes, OR
b. Use of drugs to maintain SBP > 90 mmHg at presentation before
randomization.
III. Signs of pulmonary congestion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 276
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500
-Resuscitation > 30 minutes
- Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular
septal rupture)
- Onset of shock > 12 hours
- Imminent need for mechanical circulatory support
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether outcomes for patients with cardiogenic shock is better (in terms of survival and renal functioning) when less norepinephrine is administered. ;Secondary Objective: To evaluate cost-effectiveness. ;Primary end point(s): The composite of all-cause mortality and severe renal failure requiring renal replacement therapy within 30 days after randomization.;Timepoint(s) of evaluation of this end point: 30 days after randomization
- Secondary Outcome Measures
Name Time Method