ISRCTN44822292进行中（未招募）未知
Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: the UK arm of an international multi-centre, placebo-controlled, Phase III double-blind trial
Medical University of Graz0 个研究点目标入组 2,400 人开始时间: 2020年9月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients = 18 years
- •2. Anticipated ICU stay = 48 hours
- •3. Admission to ICU = 72 hours before screening for VDD
- •4. Severe VDD (25(OH)D = 12 ng/ml [30 nmol/l]) using either the hospital's clinical laboratory or rapid bedside testing after ICU admission
排除标准
- •1. Severe gastrointestinal dysfunction (> 400 ml nasogastric tube residual volume)/unable to receive trial medication
- •2. Not expected to survive initial 48 hours of admission or treatment withdrawal imminent within 24 hours
- •3. Patient with DNAR (Do Not Attempt Resuscitation) orders in place
- •4. Hypercalcemia (> 2.65 mmol/l corrected calcium and/or > 1.35 mmol/l ionized calcium at screening)
- •5. Known kidney stones within the last 12 months
- •6. Known active tuberculosis within the last 12 months
- •7. Known sarcoidosis within the last 12 months
- •8. Women of childbearing age who have tested positive for pregnancy or who are lactating
- •9. Known hypersensitivity to the trial drug or excipient
- •10. Medical team deem it not suitable to include patient
- •11. Known prisoners in the custody of HM Prison and Probation services
研究者
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