Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT07026227
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2025-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Xuebijing in Alleviating Acute Kidney Injury After High-voltage Electrical Burns
Sponsor:
The First Hospital of Hebei Medical University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Xuebijing
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: