Fluid Resuscitation in Septic Shock Patients With BMI Elevation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Safety-time to hemodynamic stability
研究概览
简要总结
To explore the safety and feasibility of alternative fluid resuscitation strategies in obese patients with septic shock.
详细描述
Early, goal-directed therapy with timely achievement of hemodynamic stability has been shown to clearly improve outcomes in patients with septic shock. Although Surviving Sepsis Campaign guidelines recommend a weight-based approach to initial fluid resuscitation (i.e. 30ml/kg),1 at present, there are no robust data to support whether dosing based on actual body weight or an alternative correction formula (ideal body weight, adjusted body weight) is superior.
FRISSBE is a prospective, randomized, three-arm parallel-group pilot trial of alternative resuscitation strategies for obese patients with septic shock, looking at feasibility and safety of different weight-based approaches. Subject treatment assignment will not be blinded. Data will be collected and analyzed on an intent-to-treat basis. The study will enroll 60 subjects, with 20 subjects per treatment arm. Subjects will be randomized to receive one of three weight-based initial fluid resuscitation strategies - 30cc/kg ideal body weight (IBW), 30cc/kg adjusted body weight (AdjBW), or 30cc/kg actual body weight (ABW).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •18 years of age or older
- •BMI > 30
- •suspected infection, and either:
- •hypotension (a systolic blood pressure < 90mmHg) or
- •blood lactate concentration > 4mmol/L
排除标准
- •Primary diagnosis of acute cerebral vascular event
- •Acute coronary syndrome
- •Acute pulmonary edema
- •Status asthmaticus
- •Major cardiac arrhythmia
- •Active gastrointestinal hemorrhage
- •Drug overdose
- •Burns or trauma
- •Requirement for immediate surgery
- •CD4<50/mm3
- •Do-not-resuscitate order status
- •Transferred from another hospital
结局指标
主要结局
Safety-time to hemodynamic stability
时间窗: 72 hours
time from randomization to map \>65 without use of vasopressors and no lactate \>2
Feasibility1: fluid target
时间窗: 3 hours
percentage of of patients with actual volume received within 10% of target fluid volume.
Safety-vasopressors
时间窗: 24 hours
proportion of patients requiring vasopressor administration
Safety-ventilation
时间窗: 24 hours
Proportion of patients requiring invasive or noninvasive mechanical ventilation
次要结局
- feasibility2: recruitment rate(study duration)
- Exploratory: in-hospital all cause mortality(28 days)
- Exploratory: ICU length of stay(28 days)
- feasibility3: time to randomization(3 hours)
- Exploratory: hospital length of stay(28 days)