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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549376', 'term': 'Xuebijing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-10', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Creatinine (SCr) Level', 'timeFrame': 'Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.', 'description': '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.'}, {'measure': 'Change in Blood Urea Nitrogen (BUN) Level', 'timeFrame': 'Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.', 'description': '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.'}, {'measure': '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).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Neutrophil Count', 'timeFrame': 'Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.', 'description': '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.'}, {'measure': 'Change in C-Reactive Protein (CRP) Level', 'timeFrame': 'Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.', 'description': '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.'}, {'measure': 'Change in Interleukin-18 (IL-18) Level', 'timeFrame': 'Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.', 'description': '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).'}, {'measure': 'Change in Interleukin-6 (IL-6) Level', 'timeFrame': 'Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.', 'description': '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).'}, {'measure': 'Change in Superoxide Dismutase (SOD) Level', 'timeFrame': 'Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.', 'description': 'Change in serum Superoxide Dismutase activity from baseline to 7 days post-treatment. SOD is an antioxidant enzyme. Measured in U/mL.'}, {'measure': 'Change in Malondialdehyde (MDA) Level', 'timeFrame': 'Baseline (1 hour before treatment initiation) and 7 days after treatment initiation.', 'description': '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.'}, {'measure': 'Incidence of Adverse Reactions', 'timeFrame': 'Throughout the 7-day treatment period.', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'Xuebijing', 'neutrophils', 'inflammatory cells'], 'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '40830157', 'type': 'DERIVED', 'citation': 'He X, Li N, Ma L, Yang M, Ren L, Hao J, Xue X, Pang Y. 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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nThis 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.\n\nPrimary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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.\n2. Burn area greater than 30% of the total body surface area (TBSA), or third-degree burns covering more than 10% of the TBSA.\n3. All patients were admitted within 24 hours of the burn injury and survived for at least 14 days post-admission.\n4. All patients were aged ≥18 years.\n\nExclusion Criteria:\n\n1. Radiation exposure or nephrotoxic drug exposure within 5 days prior to admission.\n2. Pre-existing AKI at any stage, according to KDIGO criteria.\n3. Chronic kidney disease for any reason, with a glomerular filtration rate (GFR) ≤ 60 mL/(min•1.73 m²) for at least 3 months.\n4. Post-kidney transplant patients.\n5. Patients who had received or required continuous renal replacement therapy (CRRT) within 7 days.\n6. Anuria (urine output \\<100 mL/d) preventing sample collection.\n7. Patients with malignant tumors.\n8. Patients with autoimmune diseases requiring long-term steroid therapy.\n9. Patients who had received high-dose steroid treatment within the past month.'}, 'identificationModule': {'nctId': 'NCT07026227', 'acronym': 'Xuebijing', 'briefTitle': 'Effect of Xuebijing in Alleviating Acute Kidney Injury After High-voltage Electrical Burns', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Hebei Medical University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'S-00312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group (Xuebijing + Conventional Treatment)', 'description': 'Participants randomized to this arm received conventional treatment for acute kidney injury (AKI) following high-voltage electrical burns, plus Xuebijing injection.', 'interventionNames': ['Drug: Xuebijing Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (Conventional Treatment Only)', 'description': 'Participants randomized to this arm received conventional treatment alone for acute kidney injury (AKI) following high-voltage electrical burns.', 'interventionNames': ['Procedure: Conventional Treatment for High-Voltage Electrical Burns and AKI']}], 'interventions': [{'name': 'Xuebijing Injection', 'type': 'DRUG', 'description': 'Xuebijing injection (Tianjin Hongri Pharmaceutical Co., Ltd., National Drug Standard Z20040033).', 'armGroupLabels': ['Study Group (Xuebijing + Conventional Treatment)']}, {'name': 'Conventional Treatment for High-Voltage Electrical Burns and AKI', 'type': 'PROCEDURE', 'description': 'Standard multidisciplinary care including general burn assessment, wound management (cleaning, debridement, dressings), fluid resuscitation as per burn protocols, management of electrolyte imbalances', 'armGroupLabels': ['Control Group (Conventional Treatment Only)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'overallOfficials': [{'name': 'Yinghui Pang, BSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospital of Hebei Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xin Xue', 'investigatorAffiliation': 'The First Hospital of Hebei Medical University'}}}}