Effect of Lung Ultrasound-Guided Fluid Deresuscitation on Duration of Ventilation in Intensive Care Unit Patients (CONFIDENCE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- Ventilator free days(VFD) and alive at day 28
研究概览
简要总结
Timely recognition and treatment of fluid overload can expedite liberation from invasive mechanical ventilation in intensive care unit (ICU) patients. Lung ultrasound (LUS) is an easy to learn, safe, cheap and noninvasive bedside imaging tool with high accuracy for pulmonary edema and pleural effusions in ICU patients. The aim of this study is to assess the effect of LUS-guided deresuscitation on duration of invasive ventilation in ICU patients. The investigators hypothesize that LUS-guided fluid deresuscitation is superior to routine fluid deresuscitation (not using LUS) with regard to duration of invasive ventilation.
This study is an international multicenter randomized clinical trial (RCT) in invasively ventilated ICU patients.This study will include 1,000 consecutively admitted invasively ventilated adult ICU patients, who are expected not to be extubated within the next 24 hours after randomization. Patients are randomly assigned to the intervention group, in which fluid deresuscitation is guided by repeated LUS, or the control group, in which fluid deresuscitation is at the discretion of the treating physician (not using LUS).
详细描述
Objective:
The aim of this study is to assess the effect of LUS-guided deresuscitation on duration of invasive ventilation in ICU patients.
Hypothesis:
LUS-guided fluid deresuscitation is superior to routine fluid deresuscitation (not using LUS) with regard to duration of invasive ventilation.
Study design:
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
- •Admission to one of the participating ICUs;
- •Invasively ventilated for less than 24 hours at randomization;
- •Expected to be under invasive ventilation for longer than 24 hours after randomization.
排除标准
- •Age below 18 years old;
- •Suspected or confirmed pregnancy;
- •Participation in other interventional trials with similar endpoints;
- •Use of long term home mechanical ventilation;
- •Neurological condition that can prolong duration of mechanical ventilation (i.e.Guillain-Barré syndrome, high spinal cord lesion, amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis);
- •Conditions in which LUS cannot be performed or correctly interpreted (i.e. chest wall abnormalities, morbid obesity, and pre-existing interstitial lung disease);
- •Conditions in which targeting a negative fluid balance is discouraged (i.e. subarachnoid bleeding, severe rhabdomyolysis (CK > 20.000);
- •Previous participation in this RCT;
- •Patients transferred from another center and invasively ventilated for longer than 24 hours.
结局指标
主要结局
Ventilator free days(VFD) and alive at day 28
时间窗: 28 days after randomisation
Patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours: * VFD-28 = 0 if subject dies within 28 days of mechanical ventilation * VFD-28 = 28 - x if successfully liberated from ventilation x days after initiation Succcessful liberation: extubation (planned or unplanned) without death or reintubation within the next 72 hours * VFD-28 = 0 if the subject is mechanically ventilated for ≥ 28 days
次要结局
- Cumulative fluid balances after start of lung ultrasound examination(7 days)
- ICU length of stay(28 days)
- Hospital length of stay(28 days)
- Duration of ventilation(28 days)
- 28 day mortality(28 days)
- Incidence of acute kidney injury(28 days)
- 90 day mortality(90 days)
- Incidences of reintubations(28 days)
- Cumulative fluid balances after randomization(7 days)
研究者
Prof. Dr. Marcus J. Schultz
Prof. Dr. M.J. Schultz
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)