ISRCTN00691795已完成未知
Protection against Incidences of Serious Cardiovascular Events Study with daily fish oil supplementation in dialysis patients
Toronto General Research Institute0 个研究点目标入组 1,310 人开始时间: 2013年11月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,310
研究概览
简要总结
2024 Protocol article in https://doi.org/10.1136/bmjopen-2023-072239 (added 11/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult (age >18 years) men and women with end-stage kidney disease (ESKD) who require chronic hemodialysis (HD) 3 or 4 times/week of duration 5 hours/session or less
- •2. Clinically stable (no hospitalization or emergency room [ER] visit 1 month before enrolment)
排除标准
- •1. Reversible, acute renal failure, likely with recovery of renal function
- •2. Pregnancy
- •3. Active malignancy
- •4. Active major bleed within 1 month of enrolment
- •5. Blood pressure (BP) higher than 180/120 (malignant level)
- •6. Receiving more than two antiplatelet agents or anticoagulants i.e. use of ASA and coumadin is not an exclusion
- •7. Life expectancy of less than 6 months (i.e. palliative dialysis patients)
- •8. Implanted implantable cardioverter-defibrillators (ICD) or planned ICD placement within the year
- •9. Involvement in another drug trial
- •10. Current fish oil ingestion at the time of randomization
- •11. Any known allergy to fish or fish products
- •12. Unable to provide written informed consent (self or legal representative)
研究者
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