NCT06654895进行中（未招募）不适用
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
- 试验地点
- 10
- 主要终点
- 28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days
研究概览
简要总结
The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥22 years of age)
- •Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.
- •Sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a Sequential Organ Failure Assessment (SOFA) score ≥2
- •Septic shock: sepsis requiring vasopressors and serum lactate levels >2 mmol/L (18 mg/dL)
- •Admitted or intended to be admitted to the ICU
- •At least 3 mL plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) the earliest diagnosis of sepsis or septic shock.
排除标准
- •Prisoners or imprisonment at time of enrollment
- •Prior enrollment into this study
- •Informed consent as approved by IRB is unable to be obtained.
结局指标
主要结局
28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days
时间窗: Within 28 days after inclusion
Participants will be followed up for 28 days for all-cause mortality
次要结局
- In-hospital mortality up to 28 days(Within 28 days after inclusion)
- All-cause mortality up to 7 days(Within 7 days after inclusion)
- Sequential Organ Failure Assessment (SOFA) score(Within 28 days after inclusion)
- Hospital length of stay(Within 28 days after inclusion)
- ICU length of stay(Within 28 days after inclusion)
- Vasopressor utilization(Within 28 days after inclusion)
- Progression to septic shock(Within 28 days after inclusion)
- 28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock(Within 28 days after inclusion)
研究者
研究点 (10)
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