NCT01968746已完成不适用
The AVERT Sepsis Investigation: Assessment of Variability in Early Resuscitation and Treatment of Sepsis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Progressive organ failure
研究概览
简要总结
The overall objective of this study is to utilize heart rate variability and respiratory rate variability in patients with sepsis to predict clinical deterioration and death.
Our specific objectives are:
- To study the ability of a change in composite variability (∆CVI) assessment to act as a prognostic aid in predicting disease progression in sepsis.
- To study the effect that standard resuscitation interventions will have on the direction and magnitude of ∆CVI in patients with sepsis.
B. Hypotheses H1: In the initial resuscitation of sepsis, a low or declining multi-parameter composite variability index (CVI) over 4 hours will predict a significant increase in the combined outcome of overt shock, organ dysfunction, and mortality.
H2: In the initial resuscitation of sepsis, low volume fluid resuscitation (<20 cc/kg) over 4 hours will be associated with a low or declining CVI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Antibiotics ordered or administered (as surrogate for suspected or confirmed infection as primary reason for hospital admission as determined by the primary team)
- •Serum lactate ≥ 2.0 mmol/L or transient hypotension (any systolic blood pressure < 100 mmHg).
- •Identification within 12 hours of a qualifying lactate measurement or hypotension episode
- •Hospital admission planned for suspected infection as primary reasons for admission (per emergency medicine team).
排除标准
- •Age < 18 years
- •Non-sinus cardiac rhythm (atrial fibrillation, active pacemaker, SVT)
- •Evidence of Overt Shock upon enrollment:
- •Hypotension: SBP < 90 mmHg for ≥ 60 minutes
- •Any vasopressor or inotrope use (e.g. norepinephrine, dopamine, vasopressin, dobutamine)
- •Acute respiratory support (BiPAP or mechanical ventilation) before enrollment
- •Inability to obtain written informed consent from patient or legally authorized representative
- •Inability to wear Zephyr Bioharness device
结局指标
主要结局
Progressive organ failure
时间窗: 72 hours
A. SOFA score increase by ≥ 1 from baseline B. Overt shock C. Mortality (all-cause, in-hospital)
次要结局
未报告次要终点
研究者
研究点 (5)
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