An Observational Pilot Study for the Multi-Modality Risk Prediction and Early Identification of Critically Ill Septic Patients in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Differences in tissue oxygenation
研究概览
简要总结
The purpose of this study is to determine whether additional investigations used in other parts of healthcare can be used in the Emergency Department to identify critically ill patients quicker than usual care.
详细描述
The investigators intend to recruit 56 patients with suspected sepsis who attend the Emergency Department. The investigators want to use a device to monitor tissue oxygen levels when they first come into the Emergency Department as well as the change in tissue oxygen levels when a tourniquet is applied for 3 minutes. The investigators will take novel blood tests when the patient is having their routine bloods. Finally, the investigators will use a special camera to take specialised pictures of the small blood vessels under the tongue which will show blood flow through these vessels. The investigators will follow the recruited patients and determine if our extra data is better at determining who needs critical care. A significant proportion of patients may be too unwell or too distressed to consent to be part of this study. At the earliest opportunity, the investigators will ask patients when they have been stabilised and are able to give consent. If they say no, they will be removed from the study and their care will not be affected by this decision.
The results could help us identify septic shock as early as possible so that these unwell patients are identified early and get the correct treatment they need. This could mean starting advanced treatments usually found in the Intensive Care Unit very early on in a patient's journey.
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
- •Differential diagnosis which includes infection
- •Change in the quick Sequential Organ Failure Assessment (qSOFA) ≥2 or National Early Warning Score 2 (NEWS2) score ≥5
- •Aged ≥18 years
排除标准
- •Traumatic injury
- •Rockwood frailty score ≥6
- •Critical care therapy previously believed to not be in patient's best interests
- •Critical care therapies-initiated pre-hospital. Critical care therapies defined as:
- •4.1 Mechanical ventilation 4.2 Vasopressor/inotrope therapy 4.3 Sedation or a general anaesthetic 4.4 Pre-hospital transfusion of blood products 4.5 Extra-corporeal support
- •Advanced directive refusing critical care therapies.
- •Acute cardiac failure
- •Active gastrointestinal bleed
- •Massive pulmonary embolism
- •ICU admission declined by critical care team
- •Treated in an acute hospital <6 hours before presentation to the Emergency Department
结局指标
主要结局
Differences in tissue oxygenation
时间窗: Up to 4 hours (from baseline); 28 days (follow-up)
The difference in tissue oxygen saturation (StO2) during the vascular occlusion test in the Emergency Department between septic patients who need critical care treatment (CCT) compared to patients requiring ward care. This will be measured in % change per second..
次要结局
- Baseline of tissue oxygenation(Up to 4 hours (from baseline); 28 days (follow-up))
- Difference in blood flow of the micro-circulation (microvascular flow index)(Up to 4 hours (from baseline); 28 days (follow-up))
- Difference in blood lactate levels(Up to 4 hours (from baseline); 28 days (follow-up))
- Difference in blood flow of the micro-circulation (perfused vessel density)(Up to 4 hours (from baseline); 28 days (follow-up))
- Difference in blood tests (MR-proADM)(Up to 4 hours (from baseline); 28 days (follow-up))
- Difference in blood tests (Procalcitonin)(Up to 4 hours (from baseline); 28 days (follow-up))
- Correlation of extra investigations with standard patient outcomes(Up to 4 hours (from baseline); 28 days (follow-up))