跳至主要内容
临床试验/NCT05296590
NCT05296590进行中(未招募)不适用

Monocyte Distribution Width (MDW) in the General Population of Emergency Department Patients With and Without Bacteremia

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50,000
试验地点
2
主要终点
Observed Sensitivity and Specificity of MDW >/= 20 U in Emergency Department Patients with Positive Blood Cultures

研究概览

简要总结

This project will evaluate the usefulness of Monocyte Distribution Width (MDW) for the diagnosis of blood culture positivity (BSI) in patients in the Emergency Department (ED) and reevaluate the usefulness of MDW in patients with BSI and sepsis. Consequently, if MDW indicate a high likelihood of bacteremia antibiotic management in patients with suspected bacterial infections will be changed and aid appropriate antibiotic administration.

详细描述

BIOMARKERS for Sepsis and Infection should address important clinical aspects such as

  1. Rapid diagnosis of invasive infections contributing to organ dysfunction;
  2. Provide information regarding antibiotic susceptibility and
  3. Distinguish infection mediated organ dysfunction from non-infectious sepsis mimics.

Review of MDW values for ED patients who have positive blood cultures The gold standard for the diagnosis of bloodstream infections is positive blood cultures. Not all patients with sepsis have positive blood cultures, however patients with blood stream infections and end-organ dysfunction are septic and need to be treated with antibiotics. Two definitions of sepsis currently are used.

The sepsis-2 definitions [1,2] are based on a confirmed or suspected infectious source, a systemic response with two or more abnormal systemic inflammatory response syndrome criteria such as hyper or hypothermia, tachycardia, tachypnea and leukopenia or leukocytosis or bandemia and signs of at least one new end organ dysfunction. There is a differentiation between different degrees of disease severity between sepsis, severe sepsis and septic shock. Each of these degrees of illness severity are associated with different morbidity and mortality.

The sepsis-3 definition [3] state that sepsis is the bodies response to an infectious agent. The response is assessed using a quick SOFA score (qSOFA) assessment based on tachypnea of equal or greater than 22 breath, systolic hypotension of equal or less than 100 mmHg and changes in mentation measured by a Glasgow Coma Score (GCS) of less than 15 along with the requirement of a new onset of organ dysfunction as measured by a SOFA score of equal or greater than 2.[4] Sepsis-3 definition distinguish between sepsis and septic shock only. Septic shock is only present if a patient has 2 or more qSOFA criteria, requires the use of a vasoactive agent to maintain a mean arterial blood pressure of 70 mmHg AND if the lactate is greater than 2 mg/dL. Patients which do not have a qSOFA score of greater than 2 or a SOFA score of less than 2 are considered not septic and as having only a local infection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patients in the Main Campus Emergency Department who had blood cultures ordered

排除标准

  • Emergency Department Patients that do not have blood cultures ordered.

结局指标

主要结局

Observed Sensitivity and Specificity of MDW >/= 20 U in Emergency Department Patients with Positive Blood Cultures

时间窗: 09/2020 to 02/2023

Determine the negative predicative value of MDW assessments in Emergency Department patients at a cutoff threshold of <20 U in patients with negative blood cultures.

时间窗: 09/2020 to 02/2023

次要结局

未报告次要终点

研究者

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

Anja Kathrin Jaehne

Clinical Research Coordinator

Henry Ford Health System

研究点 (2)

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