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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06462755
Other study ID # PLAGH-AOC-R01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2009
Est. completion date December 31, 2018

Study information

Verified date June 2024
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To develop and externally validate a risk prediction model for postoperative acute kidney injury (PO-AKI) in elderly patients undergoing major noncardiac surgery, addressing the current gap in predictive tools for this vulnerable population. The endpoint was the occurrence of PO-AKI within seven days following surgery. Diagnoses were based on the Kidney Disease: Improving Global Outcomes (KDIGO) criterion. Potential PO-AKI-related perioperative data were retrieved and extracted from electronic medical record for model derivation and validation. Clinicians may consider implementing this externally validated risk prediction model to stratify elderly patients' PO-AKI risks in the early postoperative phases of noncardiac surgery in elderly patients.


Recruitment information / eligibility

Status Completed
Enrollment 57089
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years to 120 Years
Eligibility Inclusion Criteria: - elderly patients (aged = 65 years) undergoing non-cardiac surgeries Exclusion Criteria: - (1) Patients who underwent endoscopic or transplant procedures; - (2) Patients who underwent surgeries lasting longer than 10 hours; - (3) Patients who had severe preoperative kidney dysfunction, defined as preoperative sCr levels = 353.6 µmol/L, or a baseline estimated Glomerular Filtration Rate (eGFR) < 15 ml/min per 1.73 m2; - (4) Patients without sCr values at baseline or during follow-up to detect PO-AKI occurrences.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
no intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative acute kidney injury Postoperative acute kidney injury within seven days following surgery
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