Lowering blood pressure target to reduce noradrenaline use in cardiogenic shock patients
Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
This study is testing if aiming for a lower blood pressure target can help patients in cardiogenic shock use less medication and improve their chances of survival and kidney health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 776 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05168462 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and cost-effectiveness of using a lower mean arterial pressure (MAP) target of ≥ 55 mmHg compared to ≥ 65 mmHg in patients experiencing cardiogenic shock due to acute myocardial infarction. The study aims to determine if reduced use of the vasopressor noradrenaline can improve survival rates and decrease the incidence of renal failure. Participants will be closely monitored for clinical signs of organ perfusion and overall outcomes related to their treatment. The trial is conducted at the Amsterdam UMC, focusing on patients who meet specific inclusion criteria related to their condition.
Who should consider this trial
Good fit: Ideal candidates include patients with acute myocardial infarction who are experiencing cardiogenic shock and meet specific clinical criteria.
Not a fit: Patients with mechanical causes of cardiogenic shock or those requiring immediate mechanical circulatory support may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced complications for patients with cardiogenic shock.
How similar studies have performed: Other studies have explored similar approaches, but this specific methodology of targeting a lower MAP in cardiogenic shock is novel.
Eligibility criteria
Show full inclusion / exclusion 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 (i.e. ECPR) 5. Women \<45 years
Where this trial is running
Amsterdam
- Amsterdam UMC, location AMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Elma Peters
- Email: e.j.peters@amsterdamumc.nl
- Phone: 0205668380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.