Clinical trial NCT07026227: Effect of Xuebijing in Alleviating Acute Kidney Injury After High-voltage Electrical Burns
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
Xuebijing
neutrophils
inflammatory cells
Lead sponsor: The First Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Burn area greater than 30% of the total body surface area (TBSA), or third-degree burns covering more than 10% of the TBSA.
3. All patients were admitted within 24 hours of the burn injury and survived for at least 14 days post-admission.
4. All patients were aged ≥18 years.

Exclusion Criteria:

1. Radiation exposure or nephrotoxic drug exposure within 5 days prior to admission.
2. Pre-existing AKI at any stage, according to KDIGO criteria.
3. Chronic kidney disease for any reason, with a glomerular filtration rate (GFR) ≤ 60 mL/(min•1.73 m²) for at least 3 months.
4. Post-kidney transplant patients.
5. Patients who had received or required continuous renal replacement therapy (CRRT) within 7 days.
6. Anuria (urine output \<100 mL/d) preventing sample collection.
7. Patients with malignant tumors.
8. Patients with autoimmune diseases requiring long-term steroid therapy.
9. Patients who had received high-dose steroid treatment within the past month.

Primary outcomes:
measure: Change in Serum Creatinine (SCr) Level
timeFrame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
measure: Change in Blood Urea Nitrogen (BUN) Level
timeFrame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
measure: Change in 24-hour Urinary Protein Level
timeFrame: 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).
Secondary outcomes:
measure: Change in Neutrophil Count
timeFrame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
measure: Change in C-Reactive Protein (CRP) Level
timeFrame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
measure: Change in Interleukin-18 (IL-18) Level
timeFrame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
measure: Change in Interleukin-6 (IL-6) Level
timeFrame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
measure: Change in Superoxide Dismutase (SOD) Level
timeFrame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
measure: Change in Malondialdehyde (MDA) Level
timeFrame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.
measure: Incidence of Adverse Reactions
timeFrame: Throughout the 7-day treatment period.
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: First Hospital of Hebei Medical University
name: Yinghui Pang, BSN
role: PRINCIPAL_INVESTIGATOR
References: