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Acute Kidney InjuryXuebijingNCT07026227

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

A study testing Xuebijing Injection and Conventional Treatment for High-Voltage Electrical Burns and AKI in people with Acute Kidney Injury, run by The First Hospital of Hebei Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury
What is being tested?
Xuebijing Injection and Conventional Treatment for High-Voltage Electrical Burns and AKI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteChina
Study dates
20 Feb 2023to 30 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

Other trials in China

About this study

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

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.

Being tested
Xuebijing Injection, Conventional Treatment for High-Voltage Electrical Burns and AKI
Keywords
Acute Kidney Injury, Xuebijing, neutrophils, inflammatory cells
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xuebijing InjectionDrug

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

  • Conventional Treatment for High-Voltage Electrical Burns and AKIProcedure or surgery

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

Study groups in NCT07026227
Study groupRoleWhat they receive
Study Group (Xuebijing + Conventional Treatment)ExperimentalParticipants randomized to this arm received conventional treatment for acute kidney injury (AKI) following high-voltage electrical burns, plus Xuebijing injection.
Receives: Drug: Xuebijing Injection
Control Group (Conventional Treatment Only)Active comparatorParticipants randomized to this arm received conventional treatment alone for acute kidney injury (AKI) following high-voltage electrical burns.
Receives: Procedure: Conventional Treatment for High-Voltage Electrical Burns and AKI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: 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)

  1. Change in Neutrophil Count

    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.

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

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

    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.

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

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

    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).

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

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

    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).

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

  5. Change in Superoxide Dismutase (SOD) Level

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

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

  6. Change in Malondialdehyde (MDA) Level

    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.

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

  7. Incidence of Adverse Reactions

    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.

    Measured: Throughout the 7-day treatment period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2025
  2. Study start20 Feb 2023
  3. Primary completion20 Aug 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07026227
Sponsor's protocol ID
S-00312
Acronym
Xuebijing
Status last verified
Jun 2025
First submitted
4 Jun 2025
Last updated
18 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • He X, Li N, Ma L, Yang M, Ren L, Hao J, Pang Y, Xue X. 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.

    PubMed 40830157

Questions about this trial

What is this clinical trial studying?

A study testing Xuebijing Injection and Conventional Treatment for High-Voltage Electrical Burns and AKI in people with Acute Kidney Injury, run by The First Hospital of Hebei Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum Creatinine (SCr) Level (time frame: Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07026227, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.

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