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Development and Validation of a Diagnostic Model for Acute Kidney Injury Based on Ultrasound Localization Microscopy in Human Renal Allografts: A Prospective Clinical Study

Development and Validation of a Diagnostic Model for Acute Kidney Injury Based on Ultrasound Localization Microscopy in Human Renal Allografts: A Prospective Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128464
Enrollment
Unknown
Registered
2026-07-21
Start date
2026-07-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute kidney injury (AKI) is defined as an abrupt decline in renal function that includes a rapid increase in serum creatinine (sCr), decrease in urine output (UO), or both.

Interventions

Gold Standard:According to the criteria established by the Kidney Disease: Improving Global Outcomes (KDIGO) classification, AKI is staged by serum creatinine and urine output changes: Stage 1 involv
Index test:All ultrasound examinations were performed using a Vinno ULTIMUS 9E Super ultrasound system (Vinno Medical, Suzhou, China) equipped with software version 1.51.31 (BK1). The ultrasound contr
Bracco Imaging S.p.A., Milan, Italy) was used. The lyophil

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. First-time recipients of allogeneic kidney transplantation, including those receiving grafts from living donors or deceased donors; 2. Aged >= 18 years.

Exclusion criteria

Exclusion criteria: 1. Patients receiving multi-organ combined transplantation; 2. Patients who have undergone two or more kidney transplantations, or bilateral kidney transplantation (mostly recipients of pediatric donor kidneys); 3. Patients with a previous history of malignant tumors; 4. Patients with severe failure of other organs (e.g., heart, liver, lung, etc.); 5. Patients with contraindications to ultrasound contrast agents; 6. Pregnant or breastfeeding women; 7. The distance from the capsule of the middle or lower pole of the renal allograft to the skin exceeds 2.5 cm; 8. Renal allograft hydronephrosis >= 2 cm, or moderate to large peritransplant fluid collection with the maximum depth of fluid >= 2 cm, which is caused by complications including urinary tract obstruction, urinoma (urinary leakage within the first 2 weeks after transplantation), lymphocele (4–8 weeks after transplantation), perinephric infection, etc.; 9. Patients who fail to cooperate, those with unsatisfactory image acquisition, or cases with missing clinical data.

Design outcomes

Primary

MeasureTime frame
AKI;Accuracy;

Secondary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactJiaojiao Zhou

West China Hospital of Sichuan University

zhoujiaojiao@wchscu.edu.cn+86 28 85422114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026