The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis - A Prospective, Parallel-Group, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 36
- 主要终点
- Dialysis Recovery Time
研究概览
简要总结
A majority of patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD) require several hours to recover from fatigue after an HD session. Evidence for practical interventions to improve this recovery time from conventional in-center HD is lacking. This study investigates the effects of reducing HD blood flow rates on patients' self-reported post-dialysis fatigue.
详细描述
Post-dialysis fatigue reduces patients' quality of life and is also associated with cardiovascular events and mortality. Dialysis recovery time (DRT) is a measure of post-dialysis fatigue. Internationally, it has been found that more than a quarter of maintenance HD patients report >6 hours of DRT. The interventions showing the most improvement in DRT involve increases in treatment time, suggesting that post-dialysis fatigue may be in part related to the rate of solute clearance. Solute clearance rate is just one part of extending dialysis time, and its effect on DRT in patients undergoing typical-length dialysis sessions is not known. There is scant evidence to guide blood flow rate prescriptions aside from meeting clearance targets. Blood flow rate reductions are easily-implementable interventions that would slow solute clearance rates and may have an effect on post-dialysis fatigue.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of end-stage renal disease undergoing hemodialysis in the San Francisco Bay Area at approved Satellite Healthcare dialysis centers.
- •Dialysis recovery time of 6 or more hours.
- •Not hospitalized in the 7 days prior to study
排除标准
- •Currently or possibly pregnant, currently trying to become pregnant
- •Inability to provide informed consent
- •Inability to provide responses to survey questions
- •Planned move away from the current hemodialysis center within the study period
- •Undergoing nocturnal hemodialysis, planned changed to nocturnal or peritoneal dialysis, planned kidney transplant within the study period, or other major planned change in hemodialysis prescription
- •Primary nephrologist objection to enrollment
研究组 & 干预措施
Blood Flow Rate Reduction
Participants will have their hemodialysis blood flow rate reduced on their regular schedule.
干预措施: Blood Flow Rate Reduction (Other)
Control
Participants will continue to receive regularly-scheduled hemodialysis without any changes to the prescription.
干预措施: Control (Other)
结局指标
主要结局
Dialysis Recovery Time
时间窗: 4 weeks
Mean difference in change in Dialysis Recovery Time between the Blood Flow Rate Reduction group and the Control group. Dialysis recovery time is measured by asking the question, "How long did it take you to recover from dialysis?"
次要结局
- London Evaluation of Illness(4 weeks)
研究者
Brigitte Schiller-Moran, MD
Chief Medical Officer
Satellite Healthcare