跳至主要内容
临床试验/NCT05094388
NCT05094388招募中不适用

Validation of Prediction Model of Vitamin D Deficiency in Critically Ill Patients

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Area under the receiver operating characteristic

研究概览

简要总结

Many studies have pointed out that patients with vitamin D deficiency have a longer stay in the intensive care unit and a poor prognosis. The investigators' previous multi-center prospective observational study in Taiwan reveals that the prevalence of vitamin D deficiency in critically ill patients in northern Taiwan is 59%, and the prevalence of severe vitamin D deficiency is 18%. The investigators used the data of that observational study to train a predictive model for predicting vitamin D deficiency. In addition, the association between vitamin D and the immune regulation of critically ill patients in Taiwan has not been investigated. This study aims primarily to validate the performance of the prediction model of vitamin D deficiency. Moreover, this study will investigate the association between vitamin D level and inflammatory cytokine levels.

This multi-center prospective observational study will enroll critically ill patients admitted to intensive care units (ICUs) less than 28 days. After inform consent, blood will be drawn for examination of vitamin D, interleukin 6, and interleukin 10 levels. The main diagnosis of ICU admission, past medical history, vital signs within 24 hours of admission, disease severity, and laboratory data will be recorded. The predictive model will use the required parameters to predict the patient's risk of vitamin D deficiency and vitamin D severe deficiency.

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

入选标准

  • Patients admitted to intensive care units

排除标准

  • aged < 20 years
  • admitted to intensive care unit longer than 28 days
  • body max index < 18 kg/m2
  • receive vitamin D supplement > 3000 IU/day
  • previously admitted to intensive care unit within 3 months
  • have parathyroid disease, rickets, or severe liver cirrhosis [Child C]

结局指标

主要结局

Area under the receiver operating characteristic

时间窗: 1 day

Area under the receiver operating characteristic of the prediction model of vitamin D deficiency

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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