NCT06462755

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57,089

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

10 years

First QC Date

June 12, 2024

Last Update Submit

July 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with postoperative acute kidney injury

    Postoperative acute kidney injury

    within seven days following surgery

Study Arms (1)

elderly patients (aged ≥ 65 years)

elderly patients undergo surgeries

Other: No intervention

Interventions

no intervention

elderly patients (aged ≥ 65 years)

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly patients (aged ≥ 65 years) undergoing non-cardiac surgeries

You may qualify if:

  • elderly patients (aged ≥ 65 years) undergoing non-cardiac surgeries

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 17, 2024

Study Start

January 1, 2009

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 8, 2024

Record last verified: 2024-07