Contribution of Capillary Refilling Time and Skin Mottling Score to Predict Intensive Care Unit Admission of Patients With Septic or Haemorrhagic Shock Admitted to the Emergency Department
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Rate of ICU admission after ED.
研究概览
简要总结
In the emergency department (ED), the severity assessment of shock is a fundamental step prior to the admission in intensive care unit (ICU). As biomarkers are time consuming to evaluate severity of the micro and macro-circulation alteration, capillary refill time and skin mottling score are 2 simples, available clinical criteria validated to predict mortality in the ICU.
The aim of this study is to provide clinical evidence that capillary refill time and skin mottling score assessed in the ED also predict ICU admission of patients with septic or haemorrhagic shock.
详细描述
This trial is an observational, non-randomized controlled study. A total of 1500 patients admitted to the ED for a septic or hemorrhagic shock will be followed.
The primary outcome is the admission to the ICU.
The study will not impact the treatments provided to each patient. Capillary refill time and skin mottling score will not be taken into account to decide patient's treatments and/or ICU admission. Patients will be followed during their hospital stay in order to precise their destination after ED (home, ICU, ward) and 28- and 90-days mortality after hospital admission.
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
- •Age > 18 years
- •Skin mottling score> 2 and/or capillary refill time > 3secondes associated with at least one of the followings measured at the ED admission by the nurse in charge of the patient:
- •Systolic blood pressure < 90mmHg or blood pressure decrease of 30% at least for patients with high blood pressure history
- •Heart rate > 120 beats per minute
- •Respiratory rate > 22 movements per minute
- •Glasgow coma scale < 13.
排除标准
- •Age < 18 years
- •Serious co morbid conditions with a not to be reanimated status known at the ED admission
- •Patients with guardianship or curator
结局指标
主要结局
Rate of ICU admission after ED.
时间窗: 2 days
The rate of ICU admission after ED will be monitored for each patient
次要结局
- Mortality on day 90 after hospital admission(90 days)
- Mortality on day 30 after hospital admission(30 days)
研究者
Romain Jouffroy
MD
Hôpital Necker-Enfants Malades