Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 5
- 主要终点
- Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion.
研究概览
简要总结
The primary objective of this study is to establish an IL-6 concentration cutoff that predicts sepsis or septic shock (according to the Third International Consensus Definitions (Sepsis-3 criteria)) in patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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)
- •Intent to admit to hospital or admitted to the hospital via the emergency department
- •At least 0.6 mL plasma drawn (optimal 1 mL) and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of (i.e., up to 12 hours after) presentation to the emergency department. For Cohort 1, Criterion #1 criteria should be met within 3 hours of sample collection (fresh or remnant).
- •Meets criteria for at least one of the 3 cohorts (patients may be included in more than one cohort) within 12 hours of emergency department presentation:
- •1. Cohort 1 (Systemic inflammatory response or culture ordered):
- •Criterion #1 (2 of below within 3 hours of sample collection, of which 1 is at least (A) or (B))
- •A) body temperature >38C or <36C,
- •B) HR>90 beats/min,
- •C) respiratory rate >20 breaths/min, or
- •D) white blood cell count > 12K or <4K/microliters or over 10% immature forms or bands) OR:
- •Criterion #2 (order for culture of a body fluid (e.g., blood, urine, sputum))
- •2. Cohort 2 (Treatment for suspected infection initiated):
- •Meets criteria for Cohort 1 and antimicrobials (antibiotics or antivirals) ordered.
- •3. Cohort 3 (Confirmed or strong evidence of infection):
- •Meets criteria for Cohorts 1 and 2, AND 1 or more of the following criteria:
- •Temp >101F (38.3C)
- •pneumonia by x-ray or CT,
- •Urinalysis with WBC>10/HPF;
- •Intraabdominal-pelvis infection by CT, U/S, or MRI
- •Skin / soft tissue infection by clinical exam
- •Evidence of meningitis on LP;
- •Positive microbiological culture (cultures drawn within 3 days of presentation)
- •Suspected line infection (e.g. redness or pus around the line)
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.
- •Environmental exposure (e.g., heat exposure)
研究组 & 干预措施
Cohort 1: Systemic inflammatory response or culture ordered
Criterion #1: (2 of the following within 3 hours of sample collection, of which 1 is at least (A or B):
A) body temp >38c or <36c B) HR >90bpm C) respiratory rate >20 breaths/min D) white blood cell count >12k or <4k/microliters or over 10% immature forms or bands, OR Criterion #2: order for culture of a body fluid (blood, urine, sputum)
Cohort 2: Treatment for suspected infection initiated
Meets criteria for Cohort 1 and antimicrobials (antibiotics or antivirals) ordered
Cohort 3: Confirmed or strong evidence of infection
Meets criteria for Cohorts 1 and 2, AND 1 or more of the following criteria:
Temp >101F (38.3c) Pneumonia by X-ray or CT Urinalysis with WBC >10/HPF Intraabdominal-pelvis infection by CT U/S or MRI Skin/soft tissue infection by clinical exam Evidence of meningitis on LP Positive microbiological culture (cultures drawn within 3 days of presentation) Suspected line infection (e.g., redness or pus around the line)
结局指标
主要结局
Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion.
时间窗: Within 3 days after inclusion
次要结局
- Free days from renal replacement therapy (by hospital discharge or up to 30 days)(Within 30 days after inclusion)
- Free days from mechanical ventilation (by hospital discharge or up to 30 days)(Within 30 days after inclusion)
- Free days from vasopressor therapy, renal replacement therapy, or mechanical ventilation, (by hospital discharge or up to 30 days)(Within 30 days after inclusion)
- Initiation of vasopressor therapy (by hospital discharge or up to 30 days)(within 30 days after inclusion)
- Hospital Length of Stay(Participants will be followed up for hospital length of stay for up to 30 days)
- Initiation of renal replacement therapy (by hospital discharge or up to 30 days)(Within 30 days after inclusion)
- ICU length of stay(Within 30 days after inclusion)
- Initiation of mechanical ventilation (by hospital discharge or up to 30 days)(Within 30 days after inclusion)
- Free days from vasopressor therapy (by hospital discharge or up to 30 days)(Within 30 days after inclusion)
- In-hospital mortality up to 30 days(Within 30 days after inclusion)
- In-hospital mortality up to 7 days(Within 7 days after inclusion)
- Sequential Organ Failure Assessment (SOFA) score(Within 3 days after inclusion)
- Bacterial vs viral infection (As assessed by cultures and/or viral testing)(Within 30 days after inclusion)
- Progression to septic shock(Within 30 days after inclusion)
- 30-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock(Within 30 days after inclusion)