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NCT Number: NCT07026227

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Xuebijing Injection

Drug

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

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

Primary outcomes

  1. Change in Serum Creatinine (SCr) Level

    Time frame: 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.

  2. Change in Blood Urea Nitrogen (BUN) Level

    Time frame: 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.

  3. Change in 24-hour Urinary Protein Level

    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 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.

Secondary outcomes

  1. Change in Neutrophil Count

    Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.

    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.

  2. Change in C-Reactive Protein (CRP) Level

    Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.

    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.

  3. Change in Interleukin-18 (IL-18) Level

    Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.

    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).

  4. Change in Interleukin-6 (IL-6) Level

    Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.

    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).

  5. Change in Superoxide Dismutase (SOD) Level

    Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.

    Change in serum Superoxide Dismutase activity from baseline to 7 days post-treatment. SOD is an antioxidant enzyme. Measured in U/mL.

  6. Change in Malondialdehyde (MDA) Level

    Time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.

    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.

  7. Incidence of Adverse Reactions

    Time frame: Throughout the 7-day treatment period.

    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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study 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

Acronym: Xuebijing

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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