Comparison Between HA330 Hemoperfusion Filter Hemodialysis and Conventional High-Flux Filter Hemodialysis in Reducing Inflammatory Mediators in Renal Dysfunction Due to Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Interleukin (IL)-1Ra concentration before and after hemodialysis
研究概览
简要总结
The purpose of this study is to compare the effectiveness between conventional hemodialysis and hemodialysis using hemoperfusion adsorbents in renal dysfunction caused by sepsis
详细描述
This study is an open randomized clinical trial. Data were taken prospectively until the number of samples was fulfilled for analysis. Due to the intervention provided, this study was not blinded. Subjects were divided into 2 groups (group undergoing conventional hemodialysis and group undergoing HA330 hemoperfusion). Both groups underwent therapy for 4 hours, 3 times a week, with two days apart between dialysis. Inflammatory mediator levels were assessed 4 times, before and after each intervention. All subjects were given standard therapy as indicated such as antibiotics, oxygen supplementation, administration of vasopressors, nutrition, and other therapies as indicated.
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
- 否
入选标准
- •Patients age 18 - 65 years old
- •Patients diagnosed with sepsis with acute kidney injury whose indicated for hemodialysis. Including fluid overload, life-threatening metabolic acidosis, hypercalcemia, pulmonary edema, and uremic
排除标准
- •Patients with hemodynamic instability who need norepinephrine more than 0.5 microgram/kg/minute
- •Patients denied to be included in the study
结局指标
主要结局
Change in Interleukin (IL)-1Ra concentration before and after hemodialysis
时间窗: 1 week
IL-1Ra measurement using ELISA from 5 mL of veins from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. IL-1Ra will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.
Change in Interleukin (IL)-6 concentration before and after hemodialysis
时间窗: 1 week
IL-6 measurement using ELISA from 5 mL of veins from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. IL-6 will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.
Change in Interleukin (IL)-10 concentration before and after hemodialysis
时间窗: 1 week
IL-10 measurement using ELISA from 5 mL of veins from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. IL-10 will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.
Change in Tumor Necrosis Factor (TNF)-a concentration before and after hemodialysis
时间窗: 1 week
TNF-a measurement using ELISA from 5 mL of veins from central venous catheter from baseline (1 hour before first intervention) and 1 hour after intervention. TNF-a will also be measured at the 2nd (day 3) and 3rd (day 5) therapy, 1 hour before and 1 hour after treatment each.
次要结局
- Bilirubin Levels(1 week)
- Blood pH (Potential Hydrogen)(1 week)
- Neutrophils Levels(1 week)
- Procalcitonin Levels(1 week)
- Serum Glutamic Pyruvate Transaminase (SGPT) Levels(1 week)
- International Normalizing Ratio (INR)(1 week)
- Leukocytes Levels(1 week)
- Lymphocytes Levels(1 week)
- Thrombocytes Levels(1 week)
- Urea Levels(1 week)
- Creatinine Levels(1 week)
- Lactate Levels(1 week)
- C-Reactive Protein (CRP) Levels(1 week)
- Glomerular Filtration Rate (GFR)(1 week)
- Serum Glutamic Oxaloacetic Transaminase (SGOT) Levels(1 week)
- Prothrombin Time (PT)(1 week)
- Activated Partial Thromboplastin Time (aPTT)(1 week)
- Base Excess (BE)(1 week)
- PaO2 (Partial pressure of oxygen)(1 week)
- Heart Rate(1 week)
- Post ICU Routine Hemodialysis Need(30 days)
- Mean Arterial Pressure (MAP)(1 week)
- Vasoactive Drugs needed(1 week)
- Mortality(30 days)
- Length of Stay in ICU(30 days)
- Length of Stay in Hospital(30 days)
- Fluid Status(1 - 2 week)
研究者
Dita Aditianingsih
Principal investigator, Anesthesiologist Consultant
Indonesia University