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Tests treatment safety and results for Cardiogenic Shock
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
ClinicalTrials.gov ID: NCT05168462
What this study is testing
What is Reduced noradrenaline use?
Reduced noradrenaline use is an investigational medicine, being studied as a potential treatment for cardiogenic shock.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Acute myocardial infarction, STEMI or NSTEMI
- Early revascularization by PCI
- 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...
- Altered mental status
- Cold, clammy skin and extremities
You likely can't join if
- 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 (i.e. ECPR)
- Women \<45 years
See the full eligibility criteria
- Acute myocardial infarction, STEMI or NSTEMI
- Early revascularization by PCI
- 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...
- Altered mental status
- Cold, clammy skin and extremities
- Oliguria with urine output \< 30ml/hour
- Serum lactate \> 2.0 mmol/L III. Clinical signs of pulmonary congestion
- 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 (i.e. ECPR)
- Women \<45 years
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.