Weekly intravenous thiamine supplementation in chronic kidney disease and Maintenance Haemo Dialysis and effect on cognition: a randomized control study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The primary endpoint is the cognitive assessment with MOCA at the end of 24 weeks
研究概览
简要总结
This study aims to assess whether weekly intravenous thiamine injections in chronic kidney disease (CKD) patients undergoing hemodialysis (MHD) can enhance cognition, reduce the risk of delirium, lower hospital admissions, and improve quality of life. The trial is a prospective, randomized, single-center study involving two groups: one receiving thiamine injections after dialysis and a control group without the injection. The study tracks cognitive function, delirium occurrences, hospital admissions, and quality of life over 24 weeks, using cognitive assessment tools, delirium scoring, WHOQOL-BREF, and hospital admission records as endpoints. Various data, including demographics, medical history, dialysis specifics, and laboratory results, will be collected and analyzed to evaluate the impact of thiamine injections on these parameters in CKD patients undergoing MHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients above 18 years 2.On MHD for CKD for more than three months 3.Patients who agree to give consent for the study.
排除标准
- •1.Patients with diagnosed dementia like Alzheimer’s.
- •2.Patients with malignancy.
- •3.Patients who are unable to cooperate and complete study.
- •4.Patients allergic to thiamine.
- •Patients who are already on thiamine.
结局指标
主要结局
The primary endpoint is the cognitive assessment with MOCA at the end of 24 weeks
时间窗: The primary endpoint is the cognitive assessment with MOCA at the end of 24 weeks
次要结局
- 1.The number of hospital admission days in the treatment and control groups at 24 weeks.(2.Survival comparison between the treatment and control groups at 24 weeks of follow-up.)
研究者
Krishnadas N C
Meitra Hospital