ACTIVE Dialysis - A Multicentre, Unblinded, Randomised, Controlled Trial to Assess Quality of Life, Clinical Outcomes and Cost Utility for Extended vs Standard Duration of Dialysis in Patients With End Stage Kidney Disease.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 43
- 主要终点
- The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument.
研究概览
简要总结
This study will assess clinical outcomes of extended weekly hours of haemodialysis (>= 24 hours per week) compared with standard hours of haemodialysis (<=18 hours/week) in people with ESKD.
详细描述
A rapidly increasing volume of observational data suggests substantial benefits may be associated with an increased duration of dialysis. As well as improved quality of life, improved functioning and beneficial changes in a variety of laboratory parameters, it has been suggested that extended dialysis sessions might reduce mortality and major morbidity. Uncontrolled data from centres that have been providing extended dialysis shows dramatically lower mortality rates compared to those observed in centres providing standard duration dialysis. Recent analyses of extended dialysis conclude that the savings achieved in drug and hospitalization costs may lead to an overall reduction in costs compared with traditional forms of dialysis.
In this trial, we propose to examine the effects of extended dialysis (24 hours weekly or more) compared to standard dialysis (18 hours or less weekly) in patients with ESKD. The proposed study is a multi-centre, open label, randomised, controlled trial.
The study began with a pilot phase which was converted to the current main study on the receipt of peer-reviewed funding for the full study.
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
- Single (Outcomes Assessor)
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
- •Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
- •Aged 18 years or older
- •Undergoing dialysis for 18 hours per week or less
- •Suitable for either extended or standard dialysis in the view of the treating physician
- •Agreeable to randomisation
排除标准
- •Life expectancy of less than 6 months
- •Definite plans to undergo renal transplantation within 12 months of entry to the study
- •Inability to complete quality of life questionnaire
- •Concomitant major illness that would limit assessments and followup
- •High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.
结局指标
主要结局
The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument.
时间窗: 12 months from randomisation
次要结局
- Quality of life and patient acceptability(12 months)
- Changes in biochemical and haematological parameters(12 months)
- Safety outcomes(12 months)
- Costs associated with each intervention(12 months)
- Survival and cardiovascular analyses(12 months)