A Prospective Randomized, Double-Blind Parallel Group Trial To Assess The Efficacy And Safety Of Intravenous Dextrose 5% Solution Compare With Normal Saline (Standard Care) In Rinsing During Haemodialysis In Subjects With End Stage Renal Failure (ESRF) With Respect To Systolic Blood Pressure Control Over 3 Months Period.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 434
- 试验地点
- 15
- 主要终点
- systolic blood pressure control
研究概览
简要总结
This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in wash back procedure during haemodialysis in patients with end stage renal failure (ESRF) with respect to systolic blood pressure control over 3 months period.
The primary objective is to establish efficacy of 5% dextrose solution compared with normal saline (0.9% sodium chloride solution) with respect to systolic blood pressure control in subjects with end stage renal failure (ESRF) on regular hemodialysis. Secondary objectives include monitoring the change in body weight, thirst level and body fluid volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regime.
- •Have regular hemodialysisforat least 6 months or more.
- •Willing and able to provide written, signed informed consent after the nature of the study has been explained.
- •Willing and able to comply with all study procedures.
- •Age ≥18 years; Age < 75 years old
排除标准
- •Diabetes mellitus, Malignancy, Pregnancy
- •Inability or unwillingness to provide written consent.
- •Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
- •Simultaneous participation in another clinical study except observational trials
- •Any psychological condition which could interfere with the patient's ability to comply with the study protocol
- •Inability to perform a blood pressure measurement on the upper limb
- •Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period.
- •Life expectancy < 6 months
- •Recent acute myocardial infarction, congestive cardiac failure, stroke, angina or ICU admission within last 6 months,
- •Planned to migrate/move out of the city
- •Alcohol abuse/ drug abuse within last 6 months
- •Missed > 2 hemodialysis sessions over 1 month
- •Requiring non- cuff catheter for hemodialysis
- •Admitted for major infection within the last one month
研究组 & 干预措施
Normal saline
Normal saline will be used for wash back procedure at the end of hemodiaysis.
干预措施: normal saline (Drug)
dextrose 5%
Dextrose 5% will be used for wash back procedure at the end of hemodiaysis.
干预措施: Dextrose 5% (Drug)
结局指标
主要结局
systolic blood pressure control
时间窗: Time from week 0 until week 12
post intervention systolic blood pressure reduction compared to baseline
次要结局
- Interdialytic weight gain(Time from week 0 until week 12)
- thirst level(Time from week 0 and week 12)
- intradialytic event(Time from week 0 until week 12)
- adverse events(Time from week 0 until week 12)
研究者
Dr.Ong Loke Meng
doctor
Penang Hospital, Malaysia