NCT01747057Unknown不适用
Monitoring Resuscitation in Severe Sepsis and Septic Shock
Corporacion Parc Tauli2 个研究点 分布在 1 个国家目标入组 952 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 952
- 试验地点
- 2
- 主要终点
- Mortality at 28 days
研究概览
简要总结
Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious effects of fluid overload.
详细描述
To evaluate the efficacy of dynamic parameters versus static measures to guide fluid resuscitation we pretend to detect a 10% relative reduction in mortality. In addition, we pretend to observe an improvement on the length of resuscitation time, mechanical ventilation and vasopressor support-free days, ICU and hospital length of stay, organ failure and renal function.
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
- •Age > 18 years
- •Clinical evidence of sepsis (microbiology confirmation, radiological or direct view - pus in biological fluid or surgical direct view-).
- •≥ 2 SIRS criteria:
- •Temperature < 36.0°C or > 38.0°C
- •Heart rate > 90 bpm
- •Respiratory rate > 20 rpm or PaCO2 < 32 mmHg or need of mechanical ventilation.
- •Leukocytes > 12.0 x109/L or < 4.0 x109/L
- •Hemodynamic insufficiency defined as (at least one of the following):
- •Sustained systemic hypotension (systolic arterial pressure ≤ 90 mmHg or MAP < 65 mmHg) or a decrease in MAP of > 30 mm Hg in a hypertensive patient.
- •Need of vasopressors.
- •Tachycardia (HR > 110 bpm) or bradycardia (HR < 55 bpm)
- •Acute onset of oliguria, defined as a decreased urine output < 0.5 ml/kg/hr for ≥ 2 hours
- •Serum lactate > 2 mmol/l
- •Peripheral cyanosis, mottled skin, prolonged capillary refill
- •Mechanical ventilation without any kind of inspiratory effort and Vt 7-10 mL/Kg, Pplateau < 30 mmH2O. Those patients with ARDS under mechanical ventilation will need to tolerate a tidal volume of at least 7 mL/Kg during 30 seconds while the plateau pressure remains < 30 mmH2O.
- •Prior hemodynamic monitoring by arterial catheter.
- •Central venous catheter.
排除标准
- •Acute myocardial infarction < 7 days.
- •Pregnancy
- •Prior request of limited code status or expected life length lower than 3 months.
- •Shock > 12h
- •Cardiac arrhythmia
- •Aortic valvular disease
- •Inability to properly measure arterial pressure wave forms
结局指标
主要结局
Mortality at 28 days
时间窗: 28 days after hospital admission
次要结局
- Length of resuscitation(72 hours after protocol inclusion)
- Ventilator-free days(28 days after admission)
- Vasopressor-free days(28 days after admission)
- Organ failure-free days(28 days after admission)
- ICU length of stay(At ICU discharge (expected average 30 days after admission))
- Hospital length of stay(At hospital discharge (expected average 45 days after hospital admission))
- Renal function evolution(3 days after study enrollment)
- Mortality at 3 months(3 months after admission)
研究者
Antonio Artigas Raventós
Director of Critical Care Area
Corporacion Parc Tauli
研究点 (2)
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