ACTRN12614000070639招募中3 期
A randomised controlled trial of low versus normal dialysate sodium, to assess the effect on myocardial micro-injury in patients on home and self-care haemodialysis
The Centre for Clinical Research and effective practice (CCRep), registered with the New Zealand Charities Commission (ref# CC21537)0 个研究点目标入组 118 人开始时间: 2014年1月21日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Incident or prevalent patients treated with maintenance home or self-care haemodialysis for end-stage kidney failure
- •2. Aged 18 years or older
- •3. Suitable for both low and standard dialysate [Na+] in the view of the treating physician
- •4. The person is willing to participate and has signed the Participant Information and Consent Form
- •5. Pre-dialysis plasma [Na+] > or = 135mM
- •6. The treating nephrologist agrees to the person’s participation in the SOLID trial
排除标准
- •1. Haemodialysis treatments at a frequency of greater than 3.5 times per week
- •2. Treatment with maintenance haemodiafiltration
- •3. Life expectancy of less than 12 months
- •4. Scheduled for live donor kidney transplantation within 12 months of entry to the study
- •5. Considered by the treating nephrologist to have concomitant illnesses or conditions that limit or contraindicate study procedures and followup (e.g. frequent intra-dialytic hypotension requiring fluid resuscitation)
- •6. Considered by the treating nephrologist to have a high chance of non-adherence to study treatments and non-attendance for procedures and follow-up
- •7. Current enrolment in clinical studies involving antihypertensive medications, changes in HD operating parameters, or any other intervention that is likely to confound the outcome of this trial
- •8. Documented obvious infiltrative cardiomyopathies (amyloid, glycogen storage disease), hereditary cardiomyopathies (hypertrophic cardiomyopathy), or moderate to severe aortic valve disease (aortic stenosis, regurgitation)
研究者
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