CompletedNot Applicable

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

China96 participantsStarted 2023-02-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
✕

What they're measuring

Change in Serum Creatinine (SCr) Level

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

Change in Blood Urea Nitrogen (BUN) Level

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

Change in 24-hour Urinary Protein Level

Timeframe: 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).

Trial details

NCT IDNCT07026227

SponsorThe First Hospital of Hebei Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-20

View on ClinicalTrials.gov More Acute Kidney Injury trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
✕

What they're measuring

Change in Serum Creatinine (SCr) Level

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

Change in Blood Urea Nitrogen (BUN) Level

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

Change in 24-hour Urinary Protein Level

Timeframe: 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).