跳至主要内容
临床试验/NCT06178822
NCT06178822招募中不适用

Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)3 个研究点 分布在 1 个国家目标入组 3,300 人开始时间: 2022年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,300
试验地点
3
主要终点
Disease severity

研究概览

简要总结

Objectives:

  1. To compare the immune response of patients with or without sepsis presenting to the ED with a(n) (suspected) infection.
  2. To determine immune response aberrations that are associated with an increased risk of developing sepsis in patients presenting to the ED with a(n) (suspected) infection without sepsis.
  3. To determine the long term cognitive and physical sequelae of sepsis after admission.

详细描述

Sepsis will be defined in accordance with the current Sepsis 3.0 criteria as a(n) (suspected) infection with evidence of organ failure, as reflected by a SOFA (Sequential Organ Failure Assessment) score of ≥2. Notably, a molecular definition of sepsis does not exist and there is no pathological gold standard; therefore, in accordance with the current international consensus, the investigators consider the commonly used clinical organ failure (SOFA) criteria as the best option. The SOFA score is composed of six organ dysfunctions (cardiovascular, pulmonary, renal, hepatic, coagulation and neurological). The SOFA score was developed for ICU patients, but its components can be easily scored in an ED (and hospital ward) setting with the exception of the pulmonary component; this pulmonary dysfunction score is based on the PaO2/FiO2 (PF) ratio, wherein PaO2 is the partial pressure of oxygen in arterial blood and FiO2 the fraction of inspired oxygen. Measurement of the PaO2 requires an arterial blood puncture, which is not routinely done on the ER or hospital ward. Therefore, the investigators will use an alternative method to determine the respiratory SOFA by determining the SpO2/FiO2 (SF) ratio, wherein SpO2 is peripheral oxygen saturation. SpO2 is routinely measured by finger pulse oximeter in patients with suspected infection; FiO2 is 21% when breathing room temperature and increases by 4% with each liter of oxygen provided per minute to a patient via a nasal cannula. Cut-off values for SF ratios correlating with SOFA pulmonary scores based on PF ratios have been validated in large data sets.

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

  • Age 18 years or higher
  • Presentation at the Emergency Department (ED)
  • Clinical suspicion of infection or earlier confirmed infection
  • Modified Early Warning Score (MEWS) of 2 or higher

排除标准

  • No informed consent given

结局指标

主要结局

Disease severity

时间窗: During hospitalization (up to day 180)

Sequential Organ Failure Assesment (SOFA) score (minimum 0, maximum 24) collected during admission

Mortality

时间窗: 4 years

Mortality at day 30

Final diagnosis for hospitalization

时间窗: 4 years

Adjudicated diagnoses for hospitalization

次要结局

  • Length of stay(During hospitalization (up to day 180))
  • Post-sepsis sequelae(Up to 1 year after sepsis episode)
  • Mortality(5 years)
  • Readmissions(5 years)

研究者

发起方
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

W. J. Wiersinga, MD

Prof. dr. W.J. Wiersinga, MD

Amsterdam UMC, location AMC

研究点 (3)

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