Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- hospital length of stay
研究概览
简要总结
This study evaluates the effect of Vitamin D supplementation on ICU and hospital LOS in patients undergoing valve replacement surgery. Half of the patients will receive Alfacalcidol, while the other half-the control group- will be exposed to the same environment without receiving alfacalcidol.
详细描述
Vitamin D insufficiency has been reported in more than 80% of critically ill patients, hospitalized in intensive care unit (ICU), including cardiac surgical patients. Moreover, 25(OH)D levels continue to decrease from baseline throughout the hospital stay and resolves by 6 months. Vitamin D levels < 20 ng/ml is associated with higher mortality, infection rates and prolonged length of ICU saty.
The discovery of vitamin D receptors (VDR) expressed on cardiac muscle and vasculature, released a strong hypothesis suggesting that vitamin D regulates RAAS activity and cardiac remodeling.
The beneficial effects of vitamin D on cardiovascular system, immune function and wound healing could be of particular interest in critical care, and patients undergoing valve replacement surgery will benefit the most.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing mechanical valve replacement surgery
排除标准
- •combined valvular replacement surgery and Coronary Artery Bypass Graft (CABG) surgery
- •valvular replacement redo
- •valvular replacement surgery secondary to infective endocarditis
- •on dialysis
- •ALT levels 2-3 times higher than normal range
- •impaired gastrointestinal function
- •indication for vitamin D supplementation within the prior month
- •hypercalcemia defined as total calcium >10.4 mg/dl
- •hyperphosphatemia defined as serum phosphate > 4.5 mg/dl
- •pregnancy and lactation.
研究组 & 干预措施
Alfacalcidol
Patients allocated to the alfacalcidol group received 2 mcg of oral Bone Care© soft gelatin capsules once daily with food starting from the day of admission till the end of hospital stay.
干预措施: Alfacalcidol 1 MCG Oral Capsule (Drug)
结局指标
主要结局
hospital length of stay
时间窗: time to hospital discharge, up to 15 days
length of hospital stay in days starting from ICU admission to hospital discharge.
intensive-care unite length of stay
时间窗: time to ICU discharge, up to 7 days
length of hospital stay in hours starting from ICU admission to ICU discharge.
次要结局
- monitor alfacalcidol safety(during hospital stay, up tp 15 days)
- Rate of postoperative complications(during hospital stay, up to 15 days)
- mortality(during hospital stay, up to 15 days)
研究者
Sandra Nael Naguib Wahba
Teaching Assistant
Cairo University