NCT01484106已完成不适用
Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis
Cheetah Medical Inc.24 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 24
- 主要终点
- sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.
研究概览
简要总结
The primary objective of this study is to test whether a fluid resuscitation protocol guided by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in sepsis patients presenting to the Emergency Department without evidence of shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients > 18 years with old suspected or confirmed infection
- •At least two of the following four criteria (SIRS):
- •Temperature > 38 or < 36o C
- •Heart rate > 90 bpm
- •Respiratory rate > 20 bpm or PaCO2< 32 mmHg
- •White blood cell count >12,000 or <4,000 per mm3; or >10% bandemia
- •Lactate ≥2.0 and ≤4.0 mMol/L
- •Enrollment within 6 hours of ED presentation within 2.5 hours of meeting eligibility criteria
排除标准
- •Age < 18 years
- •On vasopressor therapy
- •Systolic blood pressure < 90 mmHg
- •Received more than 3-liter crystalloid fluid prior to randomization
- •Patient presenting with pulmonary edema
- •Patient presenting with acute coronary syndrome
- •Patient presenting with new onset cardiac arrhythmia
- •Patient presenting with trauma, including burns
- •Patient requires immediate surgery
- •Patient presenting with stroke
- •Patient with end stage renal disease on renal replacement therapy
- •Patient with known pregnancy
- •Patient being treated with immunosuppressive therapy for organ transplant
结局指标
主要结局
sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment.
时间窗: 72 hours
A patient will be considered to have progressive organ dysfunction if their "Sequential Organ Failure Assessment" (SOFA) score increases by ≥1 point from their baseline score within 72 hours of study enrollment.
次要结局
未报告次要终点
研究者
研究点 (24)
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