Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 103
- 试验地点
- 10
- 主要终点
- A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint
研究概览
简要总结
The purpose of this study is to evaluate the usefulness of an optimization of muscle perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with sepsis.
详细描述
The systemic inflammatory response to sepsis may cause impaired tissue oxygenation that can persist despite the restoration of a normal hemodynamic profile and systemic oxygen transport.
Therefore, the assessment of tissue oxygenation and perfusion is recommended in patients with severe sepsis.
The InSpectra tissue spectrometer relies on continuous wave near infrared (NIR) technology to estimate non invasively local tissue hemoglobin oxygen saturation in tissue (% StO2). This technology had been tested in a variety of systems: standard theoretical models of light transport, isolated blood, isolated blood-perfused animal organs and healthy human volunteers with induced limb ischemia. In critical-care medicine, NIRS has also been used to evaluate muscle oxygenation in trauma resuscitation and in lower extremity and abdominal compartment syndrome. However, NIRS has been rarely utilised to measure tissue blood flow and oxygen uptake in critically ill patients.
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
- •Two of four criteria for the systemic inflammatory response syndrome; and one of the following:
- •systolic blood pressure =< 90 mm Hg; or
- •a blood lactate concentration => 4 mmol/l; or
- •skin marbling; or
- •impaired consciousness; or
- •urine output < 30 ml/h.
排除标准
- •Age < 18 years
- •Pregnancy
- •Do-not-resuscitate status
- •Advanced directives restricting implementation of the protocol
- •Obesity (body mass index [BMI] > 30)
结局指标
主要结局
A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint
时间窗: Day 7
次要结局
- duration of mechanical ventilation(from randomization to Day 28)
- length of the hospital stay(from randomization to Day 90)
研究者
Djillali Annane
Professor in medicine
University of Versailles