Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT07026227
Eligibility Criteria:
Inclusion Criteria:
1. 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.
2. Burn area greater than 30% of the total body surface area (TBSA), or third-degree burns covering more than 10% of the TBSA.
3. All patients were admitted within 24 hours of the burn injury and survived for at least 14 days post-admission.
4. All patients were aged ≥18 years.
Exclusion Criteria:
1. Radiation exposure or nephrotoxic drug exposure within 5 days prior to admission.
2. Pre-existing AKI at any stage, according to KDIGO criteria.
3. Chronic kidney disease for any reason, with a glomerular filtration rate (GFR) ≤ 60 mL/(min•1.73 m²) for at least 3 months.
4. Post-kidney transplant patients.
5. Patients who had received or required continuous renal replacement therapy (CRRT) within 7 days.
6. Anuria (urine output \<100 mL/d) preventing sample collection.
7. Patients with malignant tumors.
8. Patients with autoimmune diseases requiring long-term steroid therapy.
9. Patients who had received high-dose steroid treatment within the past month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07026227
Study Brief:
Protocol Section:
NCT07026227