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

NCT07026227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-06-18

No results posted yet for this study

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

Interventions

DRUG

Xuebijing Injection

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

PROCEDURE

Conventional Treatment for High-Voltage Electrical Burns and AKI

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

Sponsors & Collaborators

  • The First Hospital of Hebei Medical University

    lead OTHER

Principal Investigators

  • Yinghui Pang, BSN · First Hospital of Hebei Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2023-08-20
Completion
2023-11-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07026227 on ClinicalTrials.gov