Vitamin K Supplementation to Improve INR Stability in Patients on Hemodialysis Taking Warfarin for Atrial Fibrillation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- INR stability (standard deviation of INR values)
研究概览
简要总结
The purpose of this study is to determine whether vitamin K supplementation will improve anticoagulation control in patients on hemodialysis taking warfarin for atrial fibrillation. Patients who participate will receive vitamin K1 three times a week on dialysis days for a period of four months. INR levels collected during this period will be compared to the four month period prior to receiving the vitamin K1 to determine if vitamin K improves the standard deviation of INRs and time in therapeutic range.
详细描述
Patients on hemodialysis with atrial fibrillation are at increased risk of stroke. These patients often take warfarin to reduce this risk. Warfarin is a drug that is used to prevent clots in the bloodstream. The dose of warfarin varies from person to person, and its effect is measured using a blood test called the international normalized ratio (INR). In most patients with atrial fibrillation the goal is to keep the INR between 2 and 3. Patients on hemodialysis often have unstable INR levels. Vitamin K supplementation has been shown to improve INR control in patients on warfarin but has not yet been studied in hemodialysis patients.
In this study, patients on hemodialysis receiving warfarin for atrial fibrillation will receive vitamin K 400 mcg orally three times a week on dialysis days for 4 months. INR levels in the four months before and the four months while receiving vitamin K will be reviewed.
The primary end point will look at INR stability and be measured by calculating the standard deviation of INR values before and after receiving vitamin K. The goal of this study is to determine whether vitamin K supplementation improves INR control in patients on hemodialysis taking warfarin for atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •greater than 18 years of age
- •Receiving in-house hemodialysis for at least 6 months
- •Previously diagnosed with atrial fibrillation
- •On warfarin for at least 6 months with a target INR of 2-3
排除标准
- •are unable to provide informed consent
- •have a mechanical heart valve
- •are receiving supplements containing vitamin K
- •have a known hypersensitivity to vitamin K
研究组 & 干预措施
Vitamin K1
Vitamin K1 400 mcg orally three times a week on dialysis days for four months
干预措施: vitamin K1 (Drug)
结局指标
主要结局
INR stability (standard deviation of INR values)
时间窗: 4 months before and 4 months after intervention
standard deviation of INR values, 4 months before and 4 months after the intervention
次要结局
- Time in Therapeutic Range (Percentage of time INR levels within range)(4 months before and 4 months after intervention)
- Adverse events(4 months before and 4 months after intervention)