The Effect of Thiamine, Ascorbic Acid, and Their Combination on Matrix Metalloproteinase-9 (MMP-9), Tissue Inhibitor of Metalloproteinase-1 (TIMP-1), and Inflammatory Balance (IL-6/IL-10) in Adult Sepsis Patients: A Two-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Change in serum MMP-9 concentration
研究概览
简要总结
This two-center, open-label randomized controlled trial evaluated the effect of adjunctive thiamine, ascorbic acid, and their combination compared with 0.9% saline on the extracellular matrix-remodeling axis (matrix metalloproteinase-9 [MMP-9] and tissue inhibitor of metalloproteinase-1 [TIMP-1]) and the inflammatory-balance axis (interleukin-6 [IL-6] and interleukin-10 [IL-10]) in adult patients with sepsis. Serum biomarkers were measured by ELISA at baseline and after 72 hours and related to organ dysfunction (SOFA score), acute kidney injury, and in-hospital mortality.
详细描述
Forty adults admitted to the intensive care unit with sepsis (SOFA score >= 2 and arterial lactate >= 2 mmol/L) were randomized using a computer-generated sequence to four parallel arms: control (0.9% saline), thiamine 200 mg, ascorbic acid 50 mg/kg body weight, or the thiamine plus ascorbic acid combination. Study drugs were infused over 60 minutes every 12 hours for three days, in addition to the standard hour-1 sepsis bundle. MMP-9, TIMP-1, IL-6, and IL-10 were quantified by ELISA at baseline and 72 hours. Outcomes included the MMP-9/TIMP-1 ratio, the IL-6/IL-10 balance, SOFA score, acute kidney injury, and in-hospital mortality.
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
- •Adults aged 18 years or older
- •Admitted to the intensive care unit with sepsis (Sepsis-3)
- •SOFA score >= 2
- •Arterial lactate >= 2 mmol/L
排除标准
- •* Known allergic reaction to thiamine or ascorbic acid
结局指标
主要结局
Change in serum MMP-9 concentration
时间窗: Baseline and 72 hours
Serum matrix metalloproteinase-9 (pg/mL) measured by ELISA
Change in serum TIMP-1 and MMP-9/TIMP-1 ratio
时间窗: Baseline and 72 hours
Serum TIMP-1 (pg/mL) and the MMP-9/TIMP-1 ratio by ELISA.
次要结局
- Change in serum IL-6 and IL-10 concentrations(Baseline and 72 hours)
- SOFA score(Baseline and 72 hours)
- Acute kidney injury(Through ICU discharge, up to 28 days)
- In-hospital mortality(Through hospital discharge, up to 28 days)
研究者
Bastian Lubis
Principal Investigator
Universitas Sumatera Utara