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临床试验/NCT01791712
NCT01791712已完成不适用

Enhanced Vascular Endothelial Growth Factor and Pro-inflammatory Cytokine Clearances With On-line Hemodiafiltration Versus High-flux Hemodialysis in Sepsis-related Acute Kidney Injury Patients

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2010年1月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Following the concept of "peak concentration hypothesis", which suggest the cutting peak of pro- and anti-inflammatory mediators would result in restoring a situation of immunohomeostasis. The investigators conducted the prospective randomized controlled trial aimed to compare the clearance efficacy between on-line hemodiafiltration and high-flux hemodialysis in sepsis-related acute kidney injury patients. The lowering cytokines level during sepsis is postulated to improved outcomes in sepsis.

详细描述

  1. Blood samples were taken from patients before and at the end of 4-hour in the first dialysis session. The percentage of reductions were calculated from the before and ending samples. The values of postfilter samples were corrected for changes in plasma volume, based on hemoglobin (Hb) of prefilter.
  2. VEGF and other cytokines (IL-6, IL-8, IL-10, and TNF-α) were determined in the plasma separated from EDTA blood. After collection, plasma separation was achieved by centrifugation for 10 min at 1,500 g. Immediately after separation, the samples were stored at -70 ºC until further analysis.
  3. All determinations were carried out in duplicate. The panels of cytokines (VEGF, IL-6, IL-8, IL-10, and TNF-α) were measured using the Luminex xMap-based multiplex technology. Assays were performed using the MILLIPLEX MAP (multi-analyte panels) 5-plex Cytokine Kit (Millipore, Billerica, MA) on the Luminex® instrument according to the manufacturer's procedure.

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 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •acute kidney injury (RIFLE classification F)
  • •Age more than 18

排除标准

  • •Hemodynamic instability
  • •Whom written informed consent could not be obtained

结局指标

主要结局

Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level

时间窗: At time 0-hour and 4-hour of the study dialysis session

次要结局

  • Intradialytic hypotension(During 4 hours of the study dialysis session)
  • Renal recovery (at 30 days)(participants will be followed for the renal recovery (dialysis-free) for the 30 days from the first initiation of dialysis)
  • Hospital patient mortality(participants will be followed for the duration of hospital stay (an expected average of 5 weeks))

研究者

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

Khajohn Tiranathanagul

Doctor

Chulalongkorn University

研究点 (2)

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