Determining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- The proportion of patients achieving a urine osmolality < 270 mOsm/kg
研究概览
简要总结
DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum water intake in ADPKD.
详细描述
Autosomal Dominant Polycystic Kidney Disease (PKD) affects 12.5 million people worldwide, and accounts for 7% of those requiring renal replacement therapy. The hormone vasopressin drives cyst growth until ultimately most of the normal functioning kidney tissue is replaced and compressed by cysts over the life course. Half of those affected will require dialysis by the age of 55 years.
Vasopressin blockade has emerged as a viable strategy for altering disease course. High water intake suppresses vasopressin, and may therefore slow cyst growth and consequent disease progression. However, evidence to support high water intake in PKD is lacking, and it is not clear whether patients can adhere sufficiently to a high water intake.
DRINK is a single-centre prospective, open label, parallel group randomised controlled feasibility trial. The primary objective is to establish whether a definitive large randomised trial comparing high versus ad libitum water intake on long-term disease progression is deliverable. Fifty patients will be recruited from the Renal Genetics service at Addenbrooke's Hospital. Participants will be randomly allocated to the high water intake (high) or the ad libitum (standard) water intake group. For the high intake group the aim is to drink large enough volumes of water to achieve and maintain dilute urine (urine osmolality < 270 mOsmo/kg or urine specific gravity ≤ 1.010 ). Multiple methods will be employed to promote adherence these include instruction and education as well as self-monitoring of urine specific gravity twice weekly by participants and the recording of results via a trial specific smartphone application.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have given written informed consent to participate
- •Aged 16 years or older
- •Have a diagnosis of ADPKD (fulfilling radiological diagnostic criteria ± genetic evidence)
- •eGFR ≥ 20ml/min/1.73m2
- •Able to self-monitor urine SG
排除标准
- •Inability to provide informed consent
- •eGFR < 20ml/min/1.73m2
- •Fluid overload states e.g. heart failure, cirrhosis, or requirement for fluid restriction
- •Confounding illness impacting on renal disease e.g. concomitant diabetes or glomerulonephritis
- •Treatment with diuretics for fluid overload (those on diuretics for hypertension may participate in the trial after a run-in period of 2 weeks)
- •Treatment with Tolvaptan in the last 4 weeks
- •Pregnancy or breastfeeding
结局指标
主要结局
The proportion of patients achieving a urine osmolality < 270 mOsm/kg
时间窗: 8 weeks
次要结局
- Acute change in estimated GFR(4 weeks)
- Proportion of participants that can self-monitor and report urine specific gravity reliably(8 weeks)
- Proportion of patients experiencing a serious adverse event(12 weeks)
- Health-Related Quality of Life (HRQoL)(12 weeks)
- Recruitment rate(8 weeks)
- Urine osmolality(8 weeks)
研究者
Dr Thomas Hiemstra
Honorary Consultant Nephrologist & Senior Trials Research Fellow
University of Cambridge