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临床试验/NCT06392516
NCT06392516尚未招募不适用

Effect of Intradialytic Administration of Ketoacid Analogues on Inflammatory Parameters in Patients Undergoing Chronic Hemodialysis Twice a Week

RSUP Fatmawati1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年4月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
86
试验地点
1
主要终点
interleukin-6

研究概览

简要总结

this study tries to measure the effect of intradialytic ketoacid analogues on inflammatory parameters

详细描述

this study will measure inflammation parameters:

  • interleukin 6
  • malnutrition inflammation score
  • neutrophil lymphocyte ratio
  • monocyte lymphocyte ratio
  • thrombocyte lymphocyte ratio

the duration of intervention is 12 weeks

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient who undergo hemodialysis two times a week

排除标准

  • travelling hemodialysis
  • acute conditions
  • HIV patient
  • acute infection
  • stroke and immobilized patient

研究组 & 干预措施

intervention

Experimental

will be given parenteral ketoacid analogues intradialytics two times a week

干预措施: Ketoacid (Drug)

结局指标

主要结局

interleukin-6

时间窗: 12 weeks

in pg/mL, no limit values

malnutrition inflammation score

时间窗: 12 weeks

consists of ten components, based on subjective complaints combined with albumin serum (in g/dL), serum iron (in micromol/L, and total iron binding capacity (in micromol/L). the sum of all components \>5 means have high inflammation status

monocyte lymphocyte ratio

时间窗: 12 weeks

the percentage ratio of monocyte count and lymphocyte count will be combined to monocyte lymphocyte ratio

neutrophil lymphocyte ratio

时间窗: 12 weeks

the percentage ratio of neutrophil count and lymphocyte count will be combined to neutrophil lymphocyte ratio

thrombocyte lymphocyte ratio

时间窗: 12 weeks

the percentage ratio of thrombocyte (in per microliter of blood) and lymphocyte count will be combined to thrombocyte lymphocyte ratio

次要结局

未报告次要终点

研究者

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

Anggraini Permata Sari

Internal Medicine Staff, Fellow of Nephrology Division

RSUP Fatmawati

研究点 (1)

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