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Clinical Study on the Medical Decision Level of Kidney Injury Molecule-1 Assay Kit (Fluorescence Immunochromatography)

Clinical Study on the Medical Decision Level of Kidney Injury Molecule-1 Assay Kit (Fluorescence Immunochromatography)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113222
Enrollment
Unknown
Registered
2025-11-26
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Cardiac surgery associated- acute kidney injury

Interventions

Gold Standard:KDIGO Acute Kidney Injury Staging Criteria
Index test:KIM-1 assay kit (fluorescence immunochromatography)

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.No gender restriction, age >=18 years; 2.meets the indications for cardiac surgery with cardiopulmonary bypass; 3.undergoing cardiac surgery for the first time; 4.voluntarily signed the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Preoperative unstable vital signs; 2.Suspected perioperative urinary tract infection within 3 days before or after surgery; 3.History of chronic kidney disease; 4.Preoperative renal dysfunction and/or positive urinary protein; 5.Pregnant and perinatal women; 6.Unclear case information, making it impossible to trace;

Design outcomes

Primary

MeasureTime frame
Establishing the Cut-off Value for Kidney Injury Molecule-1 Assay Kit (Fluorescence Immunochromatography) by ROC Curve Analysis;

Secondary

MeasureTime frame
Comparison of urinary KIM-1 concentration differences between AKI and non-AKI groups at different time points;

Countries

China

Contacts

Public ContactChen Chen

Nanjing Drum Tower Hospital

njchencheng@163.com+86 25 83106666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026