INCREDIBLE: INCREmental DIalysis and Diet for a Better Life Experience; Clinical Relevance of an "add-on" Ketosteril Supplementation on Incremental Haemodialysis Period in Incident Haemodialysis Patients. An Exploratory Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Duration of incremental haemodialysis period
研究概览
简要总结
Previous studies suggest that the supplementation of essential amino acids and ketaoacids may prolong the duration of the incremental phase of peritoneal dialysis. There is no data on incremental haemodialysis patients. Such data would be highly needed to support the management of haemodialysis patients in the transition phase from "pre-dialysis" to "full dose" dialysis. In this context, investigator proposed a randomized "add on" trial, to evaluate the effect of the addition of Ketosteril to the usual nutritional plan to patients who start haemodialysis in incremental way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patients (aged 18 years or older)
- •Able and accepting to give informed consent
- •Starting iHD in the Centre Hospitalier Le Mans
排除标准
- •Denying informed consent
- •Acute kidney injury (AKI)
- •Life expectancy of less than 3 months, or kidney transplantation scheduled within 3 months
- •Cognitive impairment severe enough to limit understanding and acceptance of the study
- •Impossibility to regain kidney function (bilateral nephrectomy, documented irreversible complete destruction of the kidney tissue)
- •Patient with genetic disease affecting amino acid metabolism
- •Hypercalcemia defined as calcemia beyond the upper limit of normality according to the laboratory where the test is performed and persisting for at least one month
- •Hypersensitivity to the active substances or to any of the excipients of Ketosteril
- •Non-compliance to dialysis prescription
- •Previous enrolment in a randomized study using Ketosteril
- •Currently enrolled in another interventional clinical trial
- •Protected by law (patient under guardianship, minor, prisoner, pregnant or breastfeeding woman, …)
研究组 & 干预措施
Interventional arm
Current dietary management with supplementation by Ketosteril
干预措施: Supplementation by ketosteril (Drug)
Control arm
Current dietary management, without Ketosteril
结局指标
主要结局
Duration of incremental haemodialysis period
时间窗: 24 months
Duration in months of the incremental haemodialysis period (defined as less than 3 times per week but excluding the cases in which dialysis frequency is reduced in the context of palliative and end-of life care)
次要结局
- Hospitalization rates(24 months)
- Combined outcome mortality and hospitalization(24 months)
- Mortality(24 months)
- Quality of life(24 months)
- Nutritional status(24 months)
- Costs(24 months)
- Water saving(24 months)
- Perceived diet quality(24 months)
- Energy savings(24 months)
- Waste Management(24 months)
- Assessment of Appetite(24 months)