The Effect of Bio-impedance Analysis and Vitamin D Versus Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Left ventricular mass measured by cardiac MRI
研究概览
简要总结
The main purpose of this study is to compare the effects of using bio-impedance analysis to guide management of fluid status versus routine clinical care on heart structure. In addition, Vitamin D is being assessed to determine its effect on heart structure.
详细描述
Patients on peritoneal dialysis are frequently hypervolemic which is associated with deleterious changes in left ventricular (LV) architecture including increased LV mass. In dialysis patients, increased LV mass is associated with death. Recent randomized trials have demonstrated that increasing small solute clearance is not associated with improved outcomes - hence an increased interest in the management of volume control in ESRD patients. Bioimpedance analysis is inexpensive, safe and easy to use and appears to be more useful than other techniques to assess volume status in dialysis patients. In addition, dialysis patients are vitamin D deficient and this is also associated with an increased LV mass and its inherent complications.
This study will evaluate the use of bioimpedance analysis versus usual care to assess and manage volume status and the use of vitamin D versus placebo in peritoneal dialysis patients and its effect on LV mass as measured by cardiac MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Age ≥18 years
- •on peritoneal dialysis
排除标准
- •Contraindication to MRI including presence of a pacemaker, defibrillator, ferromagnetic cerebral aneurysm clips, cochlear implants or eye prosthesis, neurostimulators, shrapnel in vital locations, surgery within 6 weeks, severe claustrophobia and severe obesity
- •Previous amputation
- •Life or technique expectancy < 1 year
- •Pregnancy
- •Peritonitis in previous 3 months
- •Currently using more than one extraneal bag per 24-hours
- •Known icodextrin allergy
- •Currently using non-Baxter PD solutions
- •Inability to provide consent
- •Allergy to cholecalciferol
- •Serum Calcium > 2.55 mmol/L
研究组 & 干预措施
Bioimpedance and Vitamin D
Bioimpedance and Vitamin D
干预措施: Bioimpedance and Vitamin D (Drug)
Usual care and Vitamin D
Usual Care and Vitamin D3
干预措施: Usual care and Vitamin D (Drug)
Bioimpedance and Placebo
Bioimpedance and Placebo
干预措施: Bioimpedance and Placebo (Device)
Usual Care and Placebo
Usual Care and Placebo
干预措施: Usual care and placebo (Drug)
结局指标
主要结局
Left ventricular mass measured by cardiac MRI
时间窗: 1 year
次要结局
- Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure(3 years)
- Volume measures: bio-impedance (RXc graph, vector length, impedance ratio, phase angle, ECW:TBW ratio), weight, N-BNP, mean and pulse arterial pressure, number of anti-hypertensive agents(3 years)
- Health-related quality of life (HRQOL)(1 year)
- Physical function as measured by 6 minute walk test(1 year)
- Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a(1 year)
- Peritoneal membrane transport properties,measured by PET(3 years)
- Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume(3 years)
- left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI(1 year)
- Fraility Score(1 year)