2025-522111-42-02尚未招募4 期
Long-term muscle synthetic effects of intradialytic parenteral nutrition in chronic hemodialysis patients
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in myofibrillar fractional synthetic rate during a one-week treatment with IDPN versus control
研究概览
简要总结
To study the effect of IDPN on muscle protein synthesis in chronic hemodialysis patients and to characterize the hemodynamic effects of IDPN.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, a participant must meet all the following criteria: - Age at least 18 years - Receiving HD treatment at least 3 months - Receiving HD treatment 3 times per week for at least 4 hours per session - 24-hour urine production < 100 mL - Adequate dialysis dose (eKt/V at least 1.2) - AV fistula with blood flow (measured invasively or by Doppler ultrasound) at least 750 mL/min
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study: - Occurrence of intradialytic hypotension in the last month, defined by systolic blood pressure < 90 mm Hg combined with a nursing intervention - Hospitalization < 3 months before inclusion - Active infection or inflammation at randomization - Use of oral or intravenous corticosteroids - Incapacitation - Patients who are not expected to be able to complete the study protocol (e.g., due to a planned kidney transplantation within the planned study time frame) - Pregnancy - Use of oral anticoagulants or antiplatelet agents that cannot be safely stopped during the study - Diabetes mellitus - AV fistula with recirculation
结局指标
主要结局
Difference in myofibrillar fractional synthetic rate during a one-week treatment with IDPN versus control
Difference in myofibrillar fractional synthetic rate during a one-week treatment with IDPN versus control
次要结局
- 1. Intradialytic forearm amino acid balance, 2. difference in the loss of amino acids in the dialysate during a one-week treatment with IDPN versus control period, 3. Effects of IDPN on intradialytic blood pressure and cardiac output.
研究者
Wesley Visser
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (1)
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