Clinical Study on the Effect of Xuebijing in Alleviating Acute Kidney Injury After High-voltage Electrical Burns by Inhibiting Neutrophils, Inflammatory Cells, and Reactive Oxygen Species
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Serum Creatinine (SCr) Level
研究概览
简要总结
High-voltage electrical burns frequently lead to acute kidney injury (AKI), a severe complication with high mortality. This study investigated the clinical efficacy and safety of Xuebijing injection, a traditional Chinese medicine preparation, in alleviating AKI in patients with high-voltage electrical burns. The study hypothesized that Xuebijing could improve renal outcomes by inhibiting neutrophils, inflammatory cells, and modulating reactive oxygen species (ROS).
This was a randomized, open-label, controlled clinical trial conducted at the Third Hospital of Hebei Medical University. Ninety-six adult patients admitted between February 2023 and December 2024 with AKI secondary to high-voltage electrical burns (burn area >30% TBSA or third-degree burns >10% TBSA, meeting AKI diagnostic criteria) were enrolled. Patients were randomized (1:1) into two groups: a study group (n=48) receiving conventional treatment plus Xuebijing injection (50 mL diluted in 100 mL 0.9% sodium chloride, IV drip, twice daily for 7 days), and a control group (n=48) receiving conventional treatment alone. Laboratory personnel assessing outcomes were blinded to group allocation where feasible.
Primary outcomes included changes in kidney function markers (Blood Urea Nitrogen [BUN], Serum Creatinine [SCr], 24-hour urinary protein), inflammatory markers (neutrophils, C-reactive protein [CRP], Interleukin-18 [IL-18], Interleukin-6 [IL-6]), and oxidative stress markers (Superoxide Dismutase [SOD], Malondialdehyde [MDA]). These were measured at baseline (1 hour before treatment) and 7 days post-treatment. Adverse reactions were also monitored.
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
- •Burns caused by high-voltage electrical injury, with a serum creatinine (Cr) level increase of at least 26.5 μmol/L within 48 hours, or urine output less than 0.5 mL/(kg•h) sustained for 6 hours, or a Cr level rising to 1.5 times the baseline within 7 days.
- •Burn area greater than 30% of the total body surface area (TBSA), or third-degree burns covering more than 10% of the TBSA.
- •All patients were admitted within 24 hours of the burn injury and survived for at least 14 days post-admission.
- •All patients were aged ≥18 years.
排除标准
- •Radiation exposure or nephrotoxic drug exposure within 5 days prior to admission.
- •Pre-existing AKI at any stage, according to KDIGO criteria.
- •Chronic kidney disease for any reason, with a glomerular filtration rate (GFR) ≤ 60 mL/(min•1.73 m²) for at least 3 months.
- •Post-kidney transplant patients.
- •Patients who had received or required continuous renal replacement therapy (CRRT) within 7 days.
- •Anuria (urine output <100 mL/d) preventing sample collection.
- •Patients with malignant tumors.
- •Patients with autoimmune diseases requiring long-term steroid therapy.
- •Patients who had received high-dose steroid treatment within the past month.
研究组 & 干预措施
Study Group (Xuebijing + Conventional Treatment)
Participants randomized to this arm received conventional treatment for acute kidney injury (AKI) following high-voltage electrical burns, plus Xuebijing injection.
干预措施: Xuebijing Injection (Drug)
Control Group (Conventional Treatment Only)
Participants randomized to this arm received conventional treatment alone for acute kidney injury (AKI) following high-voltage electrical burns.
干预措施: Conventional Treatment for High-Voltage Electrical Burns and AKI (Procedure)
结局指标
主要结局
Change in Serum Creatinine (SCr) Level
时间窗: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
Change in serum creatinine concentration from baseline to 7 days post-treatment. SCr is a key marker for assessing kidney function and injury. Measured in μmol/L.
Change in Blood Urea Nitrogen (BUN) Level
时间窗: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
Change in blood urea nitrogen concentration from baseline to 7 days post-treatment. BUN is another important marker for assessing kidney function. Measured in mmol/L.
Change in 24-hour Urinary Protein Level
时间窗: Baseline (1 hour before treatment initiation, based on a 24-hour collection prior) and 7 days after treatment initiation (based on a 24-hour collection ending on day 7).
Change in the amount of protein excreted in urine over a 24-hour period from baseline to 7 days post-treatment. This indicates the extent of glomerular and tubular damage. Measured in mg/24h.
次要结局
- Change in Neutrophil Count(Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.)
- Change in C-Reactive Protein (CRP) Level(Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.)
- Change in Interleukin-18 (IL-18) Level(Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.)
- Change in Interleukin-6 (IL-6) Level(Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.)
- Change in Superoxide Dismutase (SOD) Level(Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.)
- Change in Malondialdehyde (MDA) Level(Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.)
- Incidence of Adverse Reactions(Throughout the 7-day treatment period.)
研究者
Xin Xue
Principal Investigator
The First Hospital of Hebei Medical University