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临床试验/NCT07687498
NCT07687498已完成不适用

Effects of Intradialytic Nutrition on Dialysis Adequacy and Fatigue in Hemodialysis Patients: A Randomized Crossover Study

Mersin University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Dialysis Adequacy (spKt/V)

研究概览

简要总结

This randomized, two-period, two-sequence crossover trial aims to evaluate the effects of intradialytic nutrition on dialysis adequacy, intradialytic hemodynamic parameters, and fatigue in adults receiving maintenance hemodialysis. Participants will receive standardized intradialytic nutrition during one study period and no food intake during the other period, with each participant serving as their own control. Dialysis adequacy will be assessed using the urea reduction ratio (URR) and single-pool Kt/V (spKt/V), while fatigue will be evaluated using the Piper Fatigue Scale. Intradialytic blood pressure and other clinical parameters will also be monitored throughout the study. The findings are expected to provide evidence regarding the safety and clinical effects of intradialytic nutrition and to support individualized nutritional management strategies for patients undergoing maintenance hemodialysis.

详细描述

Chronic kidney disease is a major global health problem, and maintenance hemodialysis remains the most common renal replacement therapy for patients with end-stage kidney disease. Although hemodialysis prolongs survival, many patients experience treatment-related complications, including intradialytic hypotension, fatigue, and protein-energy wasting, all of which negatively affect quality of life and clinical outcomes.

Adequate nutritional intake is essential for preventing malnutrition in patients receiving maintenance hemodialysis. Because many patients have poor appetite before or after dialysis sessions, intradialytic nutrition has been proposed as an opportunity to improve energy and protein intake. However, the safety and clinical effects of eating during hemodialysis remain controversial. Some studies suggest that food intake during dialysis may reduce dialysis efficiency or contribute to intradialytic hypotension through postprandial hemodynamic changes, whereas other studies have reported no clinically meaningful adverse effects. Consequently, current international recommendations advocate an individualized approach rather than routine intradialytic feeding.

Fatigue is one of the most common and disabling symptoms experienced by patients undergoing maintenance hemodialysis. Although nutritional status has been associated with fatigue, limited evidence is available regarding the direct effect of intradialytic nutrition on fatigue severity. Furthermore, few randomized crossover studies have simultaneously evaluated dialysis adequacy, hemodynamic responses, and patient-reported fatigue outcomes.

This study was designed to provide clinical evidence regarding the effects of standardized intradialytic nutrition on dialysis adequacy, intradialytic hemodynamic stability, and fatigue in adults receiving maintenance hemodialysis. A randomized, two-period, two-sequence crossover design was selected to allow each participant to serve as his or her own control, thereby reducing interindividual variability. The findings are expected to contribute to evidence-based recommendations regarding individualized nutritional practices during hemodialysis and to support clinical decision-making for patients at risk of malnutrition while maintaining treatment safety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

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

  • Adults aged 18 years or older.
  • Receiving maintenance hemodialysis three times per week for at least 3 months.
  • Clinically stable.
  • Able to provide written informed consent.

排除标准

  • Active infection.
  • Hospitalization within the previous month.
  • Gastrointestinal disorders affecting oral intake.
  • Severe intradialytic hypotension requiring frequent intervention (MAP <65 mmHg).
  • Cognitive impairment.
  • Pregnancy.
  • Scheduled kidney transplantation with an available donor during the study period.

结局指标

主要结局

Dialysis Adequacy (spKt/V)

时间窗: At the end of each 4-week study period.

Dialysis adequacy was assessed using single-pool Kt/V (spKt/V)

Urea Reduction Ratio (URR)

时间窗: Assessed at the end of each 4-week study period.

Urea Reduction Ratio (URR) calculated from routine pre- and post-dialysis blood samples.

Fatigue Severity

时间窗: Assessed at the end of each 4-week study period.

Piper Fatigue Scale (22 items; total score 0-220). Higher scores indicate greater fatigue severity (worse fatigue).

次要结局

  • Intradialytic Systolic Blood Pressure(During each dialysis session throughout each 4-week study period.)
  • Intradialytic Diastolic Blood Pressure(During each dialysis session throughout each 4-week study period.)

研究者

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

Meral Gun

Profesör

Mersin University

研究点 (2)

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