跳至主要内容
临床试验/NCT05418647
NCT05418647招募中不适用

Effect of Low Versus High Dialysate Sodium Concentration During Hemodialysis on Dialysis Recovery Time: A Prospective Randomized Clinical Trial

Alexandria University3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
3
主要终点
Change in dialysis recovery time

研究概览

简要总结

This research aims to assess the effect of low versus high dialysate sodium concentration during hemodialysis on dialysis recovery time

详细描述

Chronic kidney disease (CKD) is a general term for heterogeneous disorders affecting the structure and function of the kidney. The variation in disease expression is partly related to the cause, pathology, severity and the rate of progression. Fatigue is a well-known and frequent symptom in HD patients with a reported association with the decrease in health-related quality of life commonly found in this population. The prevalence of fatigue ranges from 60% to as high as 97% in patients on long-term renal replacement therapy. Despite this fact, health care providers are still unaware of both its presence and severity. Several methods have been proposed as a way to assess post-HD fatigue with the "time to recover (minutes) from HD" being one of them. Lindsay et al.assisted patients' responses to the single open-ended question, "How long does it take you to recover from a dialysis session?". Although post-HD fatigue commonly exists in dialysis patients, it is usually underestimated by physicians. For this reason, appropriate and early identification of symptoms and associated factors might improve the patient's quality of life. Rayner et al. found that dialysate Na was inversely associated with DRT where lowering the Na concentration in the dialysate (to 140 mEq/L) was linked to a longer DRT.

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)

盲法说明

a single blinded study as participants will be unaware about the dialysate Na each patient receives

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with end-stage renal disease who have been prescribed long term hemodialysis and undergo four-hour HD treatments three times a week for more than 90 days.
  • Patient must be at least 18 years old. They must be able to read and write, as well as be in complete mental health.

排除标准

  • Inability to complete the surveys due to reading or hearing difficulties, actual instability of clinical condition that necessitate hospitalization, dementia, active malignancy or liver failure.

结局指标

主要结局

Change in dialysis recovery time

时间窗: baseline, weeks 4 and 8

By assessing the patients' responses to the single open-ended question, "How long does it take you to recover from a dialysis session?"

次要结局

  • Change in plasma sodium concentration(baseline, weeks 4 and 8)
  • Change in the inter-dialytic weight gain(8 weeks)
  • Change in blood pressure (systolic, diastolic, mean)(8 weeks)
  • Occurrence of muscle cramps(8 weeks)
  • Occurrence of headache(8 weeks)
  • Occurrence of intradialytic hypotension(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

Assistant professor & lecturer

Alexandria University

研究点 (3)

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