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临床试验/NCT07821788
NCT07821788尚未招募不适用

Clinical Outcomes and Health-Related Quality of Life in Patients Receiving Twice- Versus Thrice-Weekly Maintenance Hemodialysis: A Prospective Comparative Study

Assiut University0 个研究点目标入组 130 人开始时间: 2026年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
130
主要终点
Health-related quality of life score

研究概览

简要总结

This prospective cohort study aims to compare clinical outcomes and health-related quality of life between adults receiving established twice-weekly versus thrice-weekly maintenance hemodialysis at Assiut University Hospitals.

详细描述

Thrice-weekly maintenance hemodialysis is the conventional schedule. Twice-weekly hemodialysis is used selectively in patients with residual kidney function. Local prospective comparative data in Egypt are limited.

This observational study will include adults with end-stage kidney disease receiving established twice-weekly or thrice-weekly in-center maintenance hemodialysis. Patients will be followed according to their prescribed schedule without research-driven changes. Health-related quality of life will be assessed using the Arabic KDQOL-36 at baseline, 3 months, and 6 months. Clinical outcomes including adequacy, residual kidney function, hospitalization, and mortality will be recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • - Age 18 years or older
  • Established end-stage kidney disease requiring maintenance hemodialysis
  • Receiving in-center maintenance hemodialysis at Assiut University Hospitals
  • On maintenance hemodialysis for at least one month before enrollment
  • Established twice-weekly or thrice-weekly schedule prescribed by the treating team
  • Clinically stable at recruitment
  • Able to understand and respond to the questionnaire
  • Written informed consent

排除标准

  • - Acute kidney injury without established end-stage kidney disease
  • Hemodialysis for less than one month
  • Peritoneal dialysis or kidney transplantation during follow-up
  • Acute severe illness requiring intensive care at recruitment
  • Severe cognitive, psychiatric or neurological impairment preventing reliable questionnaire responses
  • Active malignancy with expected survival too short to complete follow-up
  • Temporary dialysis solely for an acute indication
  • Refusal to participate
  • Permanent transfer to another dialysis center during follow-up

研究组 & 干预措施

Twice-weekly hemodialysis

Adults receiving established twice-weekly maintenance hemodialysis.

Thrice-weekly hemodialysis

Adults receiving established thrice-weekly maintenance hemodialysis.

结局指标

主要结局

Health-related quality of life score

时间窗: At baseline, 3 months, and 6 months

Mean total score of the Arabic Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire.

次要结局

  • Dialysis adequacy(Up to 6 months)
  • Residual urine output(Up to 6 months)
  • Hospitalization rate(Up to 6 months)
  • Interdialytic weight gain(Up to 6 months)
  • Mortality(Up to 6 months)

研究者

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

Justin George Shawky Youssef

Resident Physician

Assiut University

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