💬In plain words
What the trial is, and whether it could suit you
The goal of this multicenter, open-label, randomized clinical trial is to learn whether norepinephrine or dopamine is more effective and safer as the first-line vasoactive drug for treating cardiogenic shock in adults. Cardiogenic shock is a life-threatening condition in which the heart cannot pump enough blood to supply the body. The main questions this study aims to answer are:
Does norepinephrine reduce the risk of death or worsening cardiogenic shock compared with dopamine?
Does norepinephrine lead to fewer complications such as arrhythmias, the need for mechanical circulatory support, or cardiac arrest?
Researchers will compare norepinephrine and dopamine to see which drug better stabilizes blood pressure, improves tissue perfusion, and prevents progression of shock during the early phase of treatment.
Participants will:
Be randomly assigned to receive either norepinephrine or
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria: 1\&2
1. Age ≥ 19
2. Cardiogenic shock (a) in the stage of Society for cardiovascular angiography and intervention (SCAI) C or D
* Cardiogenic shock (a) was defined as follows, and should fulfill both 1) and 2)
1. systolic blood pressure \<90 mm Hg for ≥30 min or need of inotropes or vasopressors to maintain systolic blood pressure \>90 mm Hg And
2. Impaired cardiac function confirmed by cardiac catheterization or echocardiography
a Cardiogenic shock was defined as follows, and should fulfill both 1) and 2)
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1. systolic blood pressure \<90 mm Hg for ≥30 min or need of inotropes or vasopressors to maintain systolic blood pressure \>90 mm Hg And
2. Impaired cardiac function confirmed by cardiac catheterization or echocardiography
* Cardiac index (CI) \< 2.2 L/min/m², measured by pulmonary artery catheter
* Left ventricular ejection fraction LVEF \< 45% on echocardiography;
* Right ventricular dysfunction, defined by one or more of: TAPSE \< 17 mm; S' \< 9.5 cm/sec; FAC \< 35%11; or visual estimation of RV wall motion abnormality.
Or Structural cardiac abnormality capable of causing cardiogenic shock, even if LV/RV systolic indices do not meet the thresholds above (examples, infarct ventricular septal rupture or severe valvular regurgitation)
Patients will be further classified based on the SCAI shock classification system12 as follows:
* SCAI B: no signs of hypoperfusion
* SCAI C: any signs of hypoperfusion, cardiogenic shock will be classified as SCAI C, and these include mental status change, cool and clammy skin, mottled skin appearance, decreased urine output (30ml/hour) or lactate over 2.0mmol/L
* SCAI D: shock progression despite use of the index vasoactive agent at ≥75% of the predefined maximal dose
* SCAI E: Impending arrest or overt circulatory collapse
Exclusion Criteria: any of these,
1. Administration of vasoactive drug more than 6 hours before enrollment
2. Receiving norepinephrine or dopamine at doses exceeding the protocol defined maximal dose at the time of enrollment.
3. Receiving any vasoactive agent other than norepinephrine or dopamine
4. Patients receiving a continuous infusion of both norepinephrine and dopamine
5. Patients already on temporary mechanical circulatory supportb before enrollment
6. Cardiogenic shock in the stage of SCAI E
7. Glasgow Coma Scale lower than 8 or other evidence of irreversible brain injury
8. Shock etiologies other than cardiogenic which include postcardiotomy shock or mixed shock
9. Pregnancy or lactation
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