Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Serum albumin
研究概览
简要总结
Design: Prospective randomised cross-over study. Fifty-two eligible patients will be randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and following a washout period of 4 weeks, switch to the alternative treatment time for an additional 24 weeks.
Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from baseline in outcome measures over a total 12-month period.
Primary outcome measure
1]Serum albumin
Secondary outcome measures Nutritional status
- Malnutrition-inflammation score
- Dietary intake
- Hand-Grip strength
- Energy expenditure
Quality of life
- Patient reported quality of life and
- time to recovery from dialysis
Serum biomarkers
- BNP
- Troponin
- MCP-1
Others 24- hour Ambulatory blood pressure 24-hour accelerometer
Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on haemodialysis treatment Duration: Fifty-six weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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
- •Dialysis dependant for over 90 days
排除标准
- •Haemodialysis for less than 90 days
- •Patients with anticipated life expectancy less than 6 months secondary to significant morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus
- •Patients with acute liver disease; History of underlying haematological condition;
- •Elective planned change of renal replacement modality within the 12 months.
研究组 & 干预措施
standard treatment time
Standard Treatment time of 4 hours
干预措施: extended treatment time (Other)
standard treatment time
Standard Treatment time of 4 hours
干预措施: Standard treatment time (Other)
Extended Treatment time
Extended treatment time of 6 hours
干预措施: extended treatment time (Other)
Extended Treatment time
Extended treatment time of 6 hours
干预措施: Standard treatment time (Other)
结局指标
主要结局
Serum albumin
时间窗: baseline to 24 weeks
次要结局
未报告次要终点