跳至主要内容
临床试验/NCT03249597
NCT03249597已完成不适用

Predict Sepsis; the Predictive Value of Bedside Measures in the Ambulance

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 956 人开始时间: 2017年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
956
试验地点
1
主要终点
Sepsis

研究概览

简要总结

Sepsis is a condition with a high mortality. Septic patients are frequently difficult to identify because of their non-specific presentations. There is also a low sensitivity of clinical judgment among health care personnel, and of existing screening tools, which are in turn typically based on vital parameters. Despite prior research, no unique sepsis biomarker has been identified so far.

There is a need for new strategies to identify sepsis which do not rely on vital parameters and traditional laboratory blood tests alone. The hypothesis of the investigators is that a combination of clinical variables measurable in the ambulance can be used to predict sepsis.

The aim of the current study is to determine the predictive value of keywords related to symptom presentation, vital parameters and point-of-care (POC) blood tests, alone and in combination, with respect to the outcome sepsis.

The study is performed in the Stockholm ambulance setting from April 2017. A total of 956 adult non-trauma patients will be included.

详细描述

Introduction

Sepsis affects at least 19 000 people in Sweden each year. Despite being a time critical condition with a high mortality, sepsis is often not identified in a timely fashion. The current study aims to identify predictors of sepsis in the ambulance setting. Early treatment is a cornerstone in sepsis. Time to treatment in the emergency department (ED) has been shown to be shortened by identification of the septic patient in the ambulance. Identification of the septic patient in the ambulance may also move the treatment to the prehospital setting.

At present, identification is dependent on the suspicion of sepsis and by health care professionals applying clinical judgment. Traditionally, the definition of sepsis has been based on the presence of infection and a minimum of two SIRS criteria (Systemic Inflammatory Response Syndrome), which have, however, been shown to be both un-sensitive and non-specific. The investigators have in previous studies proved proof of principle that a screening tool increases the identification of the septic patient and is superior to clinical judgment among both ambulance personnel and ED doctors. Moreover, these studies also illustrate that current screening tools do not identify all septic patients.

Information from the patients' medical history has not previously been incorporated in a screening tool. The investigators have previously identified keywords related to the septic patients' medical history as presented to the emergency medical services (EMS). Eight keywords showed a prevalence exceeding 20% for all septic patients, and examples were gastrointestinal symptoms and a history of abnormal temperature. However, the specificity of these keywords with respect to sepsis remains to be determined.

Also, point of care blood tests may add value in sepsis identification in the ambulance when combined with other measures. Glucose is currently measured by the Swedish EMS. Lactate testing is standard in Swedish EDs, but yet not in all ambulance services, and is used as a marker of hypoperfusion and response to treatment in sepsis. Soluble urokinase-type plasminogen activator (suPAR) has been shown to be a prognostic marker in sepsis. Heparin-binding protein (HBP) is a promising biomarker and as an early indicator of circulatory failure in sepsis. To date, no studies have analyzed the added value of suPAR or HBP to history and vital parameters.

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

入选标准

  • Adult (≥18 years)
  • Non-trauma patients (patients fallen at home can be included)
  • Transported by ambulance to one of the seven emergency hospitals of Stockholm
  • Suspected infection (prehospital infection group) or the next consecutive patient cared for in the same ambulance, immediately following a patient suspected to have a infection but not him/ herself considered suffering from an infection (prehospital control group).

排除标准

  • Patient/ relatives not speaking Swedish/English; i.e no possibility to obtain information regarding medical history.

结局指标

主要结局

Sepsis

时间窗: The first 36 hours from ED arrival.

The primary outcome sepsis will be defined, in accordance to the sepsis-3-definition (13), as infection with organ dysfunction characterized by an increase of SOFA (Sequential Organ Failure Assessment) score of ≥2 points/ requirement of vasopressor treatment /increased lactate or presence of ≥2 quickSOFA (qSOFA) criteria: respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less. According to the sepsis-3-definition, serum lactate greater than 2 mmol/L (\>18 mg/dL) is used. The sepsis diagnosis is based on an analysis of medical records from the receiving hospital for all patients having undergone the above described blood tests.

次要结局

  • Severe sepsis in accordance to former definitions.(Within 36 hours of ED arrival.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa Kurland, MD

MD, PhD, Professor in Emergency Medicine

Karolinska Institutet

研究点 (1)

Loading locations...

相似试验