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

NCT07026227 | Completed

• 1 other identifier: S-00312
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; Xuebijing; neutrophils; inflammatory cells

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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 (7)

• 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.

Study Arms (2)

Study Group (Xuebijing + Conventional Treatment)

EXPERIMENTAL

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

Drug: Xuebijing Injection

Control Group (Conventional Treatment Only)

ACTIVE COMPARATOR

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

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

Interventions

Xuebijing Injection DRUG

Xuebijing injection (Tianjin Hongri Pharmaceutical Co., Ltd., National Drug Standard Z20040033).

Study Group (Xuebijing + Conventional Treatment)

Conventional Treatment for High-Voltage Electrical Burns and AKI PROCEDURE

Standard multidisciplinary care including general burn assessment, wound management (cleaning, debridement, dressings), fluid resuscitation as per burn protocols, management of electrolyte imbalances

Control Group (Conventional Treatment Only)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Related Publications (1)

• He X, Li N, Ma L, Yang M, Ren L, Hao J, Xue X, Pang Y. Xuebijing alleviates high-voltage electrical burn-induced acute kidney injury by inhibiting neutrophils and inflammation. Sci Rep. 2025 Aug 19;15(1):30410. doi: 10.1038/s41598-025-11977-w.

  PMID: 40830157 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Xuebijing

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yinghui Pang, BSN

  First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 18, 2025
• Study Start: February 20, 2023
• Primary Completion: August 20, 2023
• Study Completion: November 30, 2023
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)