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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Reduction in plasma Vascular Endothelial Growth Factor (VEGF)level
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
- 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.
- 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.
- 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
研究组 & 干预措施
On-line hemodiafiltration
On-line hemodiafiltration is a type of renal replacement therapy that was assigned as the intervention to compare with the control arm
干预措施: On-line hemodiafiltration (Procedure)
High-flux hemodialysis (control)
The standard high-flux hemodialysis is the routine renal replacement therapy in sepsis-related acute kidney injury patients and is assigned as the intervention for the control group.
干预措施: High-flux Hemodialysis (Procedure)
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
Khajohn Tiranathanagul
Doctor
Chulalongkorn University