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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Xuebijing injection (Tianjin Hongri Pharmaceutical Co., Ltd., National Drug Standard Z20040033).
Standard multidisciplinary care including general burn assessment, wound management (cleaning, debridement, dressings), fluid resuscitation as per burn protocols, management of electrolyte imbalances
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Change in Serum Creatinine (SCr) Level
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.
Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
Change in Blood Urea Nitrogen (BUN) Level
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.
Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
Change in 24-hour Urinary Protein Level
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.
Time frame: 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 Neutrophil Count
Change in peripheral blood neutrophil count from baseline to 7 days post-treatment. Neutrophils are key inflammatory cells involved in AKI pathogenesis. Measured in 10\^9/L.
Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
Change in C-Reactive Protein (CRP) Level
Change in serum C-reactive protein concentration from baseline to 7 days post-treatment. CRP is a systemic marker of inflammation. Measured in mg/L.
Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
Change in Interleukin-18 (IL-18) Level
Change in serum Interleukin-18 concentration from baseline to 7 days post-treatment. IL-18 is a pro-inflammatory cytokine implicated in kidney injury. Measured in ng/mL (or pg/mL, check units from actual lab).
Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
Change in Interleukin-6 (IL-6) Level
Change in serum Interleukin-6 concentration from baseline to 7 days post-treatment. IL-6 is another key pro-inflammatory cytokine. Measured in ng/mL (or pg/mL, check units from actual lab).
Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
Change in Superoxide Dismutase (SOD) Level
Change in serum Superoxide Dismutase activity from baseline to 7 days post-treatment. SOD is an antioxidant enzyme. Measured in U/mL.
Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
Change in Malondialdehyde (MDA) Level
Change in serum Malondialdehyde concentration from baseline to 7 days post-treatment. MDA is a marker of lipid peroxidation and oxidative stress. Measured in nmol/mL.
Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
Incidence of Adverse Reactions
Number and type of adverse reactions (e.g., skin rashes, nausea, fever, abdominal pain, etc.) reported by participants or observed by investigators in each group during the 7-day treatment period.
Time frame: Throughout the 7-day treatment period.
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