Effect of Xuebijing in Alleviating Acute Kidney Injury After High-voltage Electrical Burns

Hebei Medical University

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Procedure: Conventional Treatment for High-Voltage Electrical Burns and AKI; Drug: Xuebijing Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07026227

S-00312

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Study Group (Xuebijing + Conventional Treatment)

Experimental group

Description:

Participants randomized to this arm received conventional treatment for acute kidney injury (AKI) following high-voltage electrical burns, plus Xuebijing injection.

Treatment:

Drug: Xuebijing Injection

Control Group (Conventional Treatment Only)

Active Comparator group

Description:

Participants randomized to this arm received conventional treatment alone for acute kidney injury (AKI) following high-voltage electrical burns.

Treatment:

Procedure: Conventional Treatment for High-Voltage Electrical Burns and AKI