Assessing Catecholamine Treatment Initiation Options: Norepinephrine vs Dopamine for Cardiogenic Shock
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 512
- 试验地点
- 1
- 主要终点
- A composite of 28-day all-cause death or signs of progressive or refractory cardiogenic shock within the first 24 hours
研究概览
简要总结
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 dopamine as the first vasoactive drug
Receive treatment and monitoring based on current clinical guidelines for cardiogenic shock
Undergo regular assessments of blood pressure, laboratory values, heart rhythm, and organ function during hospitalization
Be followed for outcomes at 1 month, 6 months, and 1 year after enrollment
This study aims to provide evidence that will help determine which initial vasoactive drug offers better outcomes for patients with cardiogenic shock and guide future treatment recommendations.
详细描述
Cardiogenic shock is a severe form of acute circulatory failure characterized by inadequate cardiac output, tissue hypoperfusion, and high short-term mortality. Despite advances in revascularization, mechanical circulatory support, and critical care management, early hemodynamic stabilization remains a major determinant of clinical outcomes. Vasoactive drugs are essential components of initial therapy, yet the optimal first-line agent for cardiogenic shock has not been definitively established.
Norepinephrine and dopamine are widely used vasoactive agents, but they may exert their effects through different physiological mechanisms. Their relative impact on vascular tone, cardiac output, and heart rate can vary depending on dose, patient characteristics, and the underlying pathophysiology of shock. Prior studies, including observational analyses and a landmark randomized trial, have suggested potential differences in safety profiles-particularly regarding arrhythmias-but these findings have not been confirmed in a contemporary population with standardized shock definitions and modern management strategies.
This multicenter, open-label, randomized clinical trial is designed to compare norepinephrine and dopamine as the initial vasoactive drug in adults with cardiogenic shock. The study uses a protocol-defined dosing algorithm to ensure consistent titration and incorporates current guideline-based management across participating centers. The primary endpoint evaluates both early hemodynamic deterioration and 28-day mortality, reflecting clinically meaningful outcomes during the most vulnerable phase of shock.
By enrolling a large, diverse population across multiple centers, this trial aims to provide definitive evidence regarding the comparative effectiveness and safety of norepinephrine versus dopamine as first-line therapy. The results are expected to inform clinical guidelines and support standardized treatment strategies for patients with cardiogenic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiogenic shocka 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)
- •systolic blood pressure <90 mm Hg for ≥30 min or need of inotropes or vasopressors to maintain systolic blood pressure >90 mm Hg And
- •Impaired cardiac function confirmed by cardiac catheterization or echocardiography
- •Patients will be further classified based on the SCAI shock classification system 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: requirement of second-line vasoactive drug or mechanical circulatory support based on the predefined treatment protocol
排除标准
- •any of these,
- •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
研究组 & 干预措施
Norepinephrine First-Line Vasoactive Drug
Participants assigned to this arm will receive norepinephrine as the first-line vasoactive drug for the treatment of cardiogenic shock. The drug will be initiated and titrated according to the protocol-defined dosing algorithm, with adjustments based on hemodynamic response, laboratory values, and clinical status. If participants were receiving vasoactive agents before randomization, norepinephrine will be started at an equivalent protocol-defined dose, and other agents will be tapered as clinically appropriate. All treatment and monitoring will follow current clinical guidelines for cardiogenic shock.
干预措施: Norepinephrine (Drug)
Dopamine First-Line Vasoactive Drug
articipants assigned to this arm will receive dopamine as the first-line vasoactive drug for the treatment of cardiogenic shock. The drug will be initiated and titrated according to the protocol-defined dosing algorithm, with adjustments based on hemodynamic response, laboratory values, and clinical status. If participants were receiving vasoactive agents before randomization, dopamine will be started at an equivalent protocol-defined dose, and other agents will be tapered as clinically appropriate. All treatment and monitoring will follow current clinical guidelines for cardiogenic shock.
干预措施: Dopamine Agent (Drug)
结局指标
主要结局
A composite of 28-day all-cause death or signs of progressive or refractory cardiogenic shock within the first 24 hours
时间窗: 28 days
signs of progressive or refractory cardiogenic shock within the first 24 hours, defined as follows, any of: * Sustained low blood pressure (mean arterial pressure \< 60mmHg) more than 30 minutes * Lactate over 4 mmol/L, higher than initial lactate level at 6 hours after randomization * Initiation of treatment with mechanical circulatory support * Initiation of second-line vasoactive drug * Cardiac arrest requiring cardiopulmonary resuscitation * Arrhythmia requiring electrical cardioversion \*\*For patients who experience more than one qualifying event, the primary endpoint will be determined based on the first event that occurs.
次要结局
- Number of participants who initiate a second-line vasoactive drug within the first 24 hours(the first 24 hours)
- All-cause death at 28th day(28 days)
- Cardiovascular death at 28th day(28 days)
- Number of participants who develop signs of progressive or refractory cardiogenic shock within the first 24 hours(the first 24 hours)
- Number of participants who initiate mechanical circulatory support within the first 24 hours(the first 24 hours)
- Number of participants with cardiac arrest requiring cardiopulmonary resuscitation within the first 24 hours(the first 24 hours)
- Number of participants with arrhythmia requiring electrical cardioversion within the first 24 hours(the first 24 hours)
- Number of participants who receive cardiac replacement treatment (temporary or durable mechanical circulatory support or heart transplantation) within the first 28 days(First 28 days)
- Number of participants with first-time initiation of renal replacement therapy for acute kidney injury (AKI) during initial hospitalization(First 28 days)
- Duration of vasoactive drug use (hours) during initial hospitalization(First 28 days)
- Number of participants with new-onset or recurrent atrial or ventricular arrhythmia requiring pharmacologic or electrical cardioversion during initial hospitalization(First 28 days)
- Number of participants who develop acute limb ischemia requiring surgical or interventional treatment during initial hospitalization(First 28 days)
- Number of participants who develop ischemic or hemorrhagic stroke during initial hospitalization(First 28 days)
- All-cause death at 1 year(1 year)
- Cardiovascular death at 1 year(1 year)
- Number of participants with rehospitalization due to heart failure within 1 year(1 year)
- Number of participants with first-time initiation of renal replacement therapy at 1 year(1 year)
研究者
Min Chul Kim
Professor, MD, PhD
Chonnam National University Hospital