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临床试验/NCT04284423
NCT04284423Unknown不适用

Study of Synovial Lactate Level as Marker of Septic Arthritis

Khoo Teck Puat Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年2月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Lactate level of synovial fluid

研究概览

简要总结

Lactate levels are rapidly available and may potentially aid in diagnosing septic arthritis in a native joint. This study will determine the utility of synovial lactate in discriminating septic from aseptic arthritis.

详细描述

A painful, swollen joint can be caused by variety of conditions. Distinguishing bacterial arthritis and other causes of arthritis is essential to reducing significant morbidity and mortality. In most cases, septic arthritis is monoarticular and occurs most commonly in large peripheral joints, such as the knee.

Current recommended diagnostic tools include clinical suspicion after examination followed by testing of synovial fluid from the affected joint. The gold standard is often gram stain or synovial fluid culture. The early markers such as synovial WBC, polymorphonuclear white blood cells are not accurate in predicting the diagnosis of septic arthritis. This leads to diagnostic dilemmas, inappropriate admissions, and unnecessary costs pending the results of synovial fluid cultures.

The current emergency department protocol for the diagnosis of septic arthritis states that if none of the following criteria is met, it is unlikely to be septic arthritis:

  1. synovial fluid white cell count more than 50 000/uL; or
  2. synovial fluid neutrophil more than 75%; or
  3. positive gram stain.

However, it has been noted that septic arthritis can have white cell counts lower than 50 000/uL which means that the current protocol cannot safely rule out septic arthritis. A neutrophil percentage of at least 90% has a reported specificity ranging from 68 to 83% while our current protocol uses a cut off of 75% which has a low specificity resulting in many unnecessary admissions. A high neutrophil percentage is also seen in inflammatory joint conditions, and therefore may not be adequate to distinguish infective from non-infective joint pain. A recent review of existing studies in 2011 stated "Future ED-based diagnostic trials are needed to evaluate the role of clinical gestalt and the efficacy of nontraditional synovial markers such as lactate".

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Lactate level of synovial fluid

时间窗: The duration of study is one year.

Lactate levels of joint fluid of suspected infected knee joint. The gold standard for infected joint will be performance of washout procedure or positive gram stain or culture.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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