None listed
Conditions
Interventions
Drug : The ACTION-CS trial is a prospective, multicenter, randomized, open-label clinical study comparing norepinephrine and dopamine as the first-line vasoactive agent in patients with cardiogenic sh
no fixed treatment duration is mandated by the protocol.
If a patient is already receiving vasoactive agents at the time of randomization, the assign
Sponsors
Chonnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age =19 years Cardiogenic shock in the stage of Society for cardiovascular angiography and intervention (SCAI) C or D Cardiogenic shock was defined as follows, and should fulfill both 1) and 2) 1) systolic blood pressure 90 mm Hg And 2) Impaired cardiac function confirmed by cardiac catheterization or echocardiography Patients will be further classified based on the SCAI shock classification system as follows: - 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), renal dysfunction or lactate over 2.0mmol/L - SCAI D: requirement of second-line vasoactive drug or mechanical circulatory support based on the predefined treatment protocol - SCAI E: rapid progression of CS, to the status of impending collapse or cardiac arrest
Exclusion criteria
Exclusion criteria: Administration of vasoactive drug more than 6 hours before enrollment Patients already on temporary mechanical circulatory supportb before enrollment Glasgow Coma Scale lower than 8 or other evidence of irreversible brain injury Shock etiologies other than cardiogenic which include postcardiotomy shock or mixed shock Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of 28-day all-cause death or signs of progressive or refractory cardiogenic shock within the first 24 hours, defined as any of the following: 1) Sustained low blood pressure (mean arterial pressure 4 mmol/L and higher than the initial lactate level at 6 hours after randomization 3) Initiation of treatment with mechanical circulatory support 4) Initiation of a second-line vasoactive drug 5) Cardiac arrest requiring cardiopulmonary resuscitation 6) Arrhythmia requiring electrical cardioversion | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause death;Cardiovascular death ;Signs of progressive or refractory cardiogenic shock;Initiation of treatment with mechanical circulatory support ;second-line vasoactive drug within the first 24 hours ;Cardiac arrest requiring cardiopulmonary resuscitation ;Arrhythmia requiring electrical cardioversion;Cardiac replacement treatment (temporary, durable mechanical circulatory support or heart transplantation;Cardiac arrest requiring cardiopulmonary resuscitation;First-time initiation of renal replacement during initial hospitalization;Duration of vasoactive drug use (hours) during initial hospitalization;New-onset or recurrent (in the cases of previous diagnosis) atrial or ventricular arrhythmia requiring pharmacologic or electrical cardioversion during initial hospitalization;Acute limb ischemia requiring surgical or interventional treatment during initial hospitalization;Ischemic or hemorrhagic stroke during initial hospitalization;All-cause death ;Cardiovascular death ;Rehospitalization due to heart failure ;First-time initiation of renal replacement treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactYongwhan Lim
Chonnam National University Hospital
Outcome results
None listed