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临床试验/NCT05580016
NCT05580016已完成不适用

Prognostic Value of Soluble Urokinase Plasminogen Activation Receptor (SUPAR) to Rule Out Complications in Patients Admitted in Emergency Department for Acute Abdominal Pain.

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月9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
200
试验地点
1
主要终点
Occurrence of medical and surgical complications within 7 days

研究概览

简要总结

Soluble Urokinase Plasminogen Activation Receptor (SUPAR) is a validated biomarker with applications in the study of inflammation and infection.

Elevated levels of SUPAR have recently been linked to a higher mortality in patients suffering from undifferentiated sepsis, pneumonia, and more recently, COVID-19 infection.

Large randomized controlled trials have been conducted on patients admitted to the emergency department (ER), regardless of the reason for admittance.

These studies have stratified risk based on three cutoffs at initial measurement:

  • Low risk : < 3 ng/mL
  • Intermediate risk : entre 3 et 6 ng/mL
  • High risk : > 6 ng/mL Low levels of SUPAR are associated with low risk of mortality in the short and long term in patients presenting to the ED, no matter the reason for admittance. Risk stratification could be an added decision-making tool for clinicians to comfort hospital discharge.

To the best of our knowledge, there is no available data on the added value of SUPAR for predicting mortality in abdominal sepsis and abdominal pain.

Abdominal pain is responsible for 10 to 30 % of ER admissions. Consequently, abdominal pain is then responsible for roughly 10 % of admissions into medical and surgical wards. Mortality varies depending on patient factors. Mortality is usually stratified on age. In patients under 50 years of age, it is near 8%, but it reaches 19 % in patients over 50.

Diagnostic accuracy also decreases drastically with age, reaching approximately 30 % patients over 75.

Taking this into account, integrating a measure of SUPAR levels into the current standard of care could stratify the risk of complications in patients admitted to the ER with abdominal pain.

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

  • Over 18 years of age
  • Presenting to the ED with abdominal pain for over an hour
  • Classified as category 2 or above on the CIMU or FRENCH severity scale
  • Necessitating bloodwork at the discretion of the consulting physician
  • Who gave his Non-opposition after clear and fair information on the study

排除标准

  • With pain evocative of kidney stones
  • With a chronic inflammatory disease: HIV infection, inflammatory bowel disease, rheumatoid arthritis, cancer
  • Chronic renal disease
  • Under hospice care
  • Intubated
  • Unstable hemodynamically
  • Transferred from a secondary care facility and having undergone previous bloodwork
  • Patient unable to understand the information and to give his non-objection
  • under guardianship, curatorship or subordination;
  • benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in an establishment health or social, adults under legal protection

结局指标

主要结局

Occurrence of medical and surgical complications within 7 days

时间窗: 7 days

7 -day complications as a composite outcome of either: * Necessity of surgical intervention * Hospitalisation lasting over 24 hours * Death in direct relation to the reason for admittance * Hospital readmission for abdominal pain in a similar abdominal quadrant

次要结局

  • Comparison with routine biomarkers(30 days)
  • Optimal cutoff(7 days)
  • Occurrence of medical and surgical complications within 30 days(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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