Effectiveness of the MINUTES Bundle for Initial 30-Minute Management of Undifferentiated Circulatory Shock in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 202
- 主要终点
- Shock reversal within 6 hours (MAP ≥65 mmHg without vasopressors + improved perfusion)
研究概览
简要总结
This study aims to validate the effectiveness of the MINUTES bundle on clinical outcomes in patients presenting with undifferentiated shock.
详细描述
Undifferentiated circulatory shock represents a critical challenge in emergency medicine (1), requiring rapid assessment and immediate intervention to prevent organ failure and death. Early goal-directed therapy (EGDT) and time-sensitive bundles have proven beneficial in improving outcomes. While specific shock types (e.g., septic, cardiogenic) have established guidelines (2-6), there is limited structured guidance for the initial 30-minute management "golden half hour" of resuscitation when the cause is unknown.
The MINUTES bundle, proposed in recent expert opinion (7), offers a structured approach to streamline early resuscitation and evaluation steps. It includes:
- Maintain ABCs (airway, breathing, circulation)
- INfuse vasopressors/fluids and INvestigate basic labs
- Ultrasound (POCUS)
- Treat underlying Etiology
- Stabilize systemic perfusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
This is an open-label trial. Due to the nature of the intervention (implementation of the MINUTES bundle in the emergency department), blinding of participants, care providers, and investigators is not feasible.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adults 18-65 years old
- •2. Clinical signs of circulatory shock:
- •SBP <90 mmHg or MAP <65 mmHg
- •Signs of hypoperfusion (altered mental status, oliguria, elevated lactate)
- •No clear etiology of shock at time of triage
排除标准
- •1- Trauma-related shock 2- Known terminal illness- Transferred after prior resuscitation 4- Pregnant patients 5-Patients with cardiac arrest upon arrival
结局指标
主要结局
Shock reversal within 6 hours (MAP ≥65 mmHg without vasopressors + improved perfusion)
时间窗: Minute bundle in initial 30-minute management Shock reversal within 6 hours
次要结局
未报告次要终点
研究者
Omnia Esaam Abdelhady
Effectiveness of the MINUTES Bundle for Initial 30-Minute Management of Undifferentiated Circulatory Shock in the Emergency Department
Assiut University