Perioperative Database of Chinese Elderly Patients for Po... | NCT06462755

Studies
Perioperative Database of Chinese Elderly Patients for Postoperative Acute Kidney Injury

NCT06462755

Sponsor

Chinese PLA General Hospital

Status

Completed

Last Update Posted

Jul 8, 2024Actual

Enrollment

57,089Actual

Phase

Not provided

Conditions

Postoperative Acute Kidney Injury

Interventions

No intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2009Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jun 12, 2024

First Submission Date that Met QC Criteria

Jun 12, 2024

First Posted Date

Jun 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2024

Last Update Posted Date

Jul 8, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Weidong Mi, Director (Cheif expert of National key research and development program of China 2018YFC2001900), Chinese PLA General HospitalPrincipal Investigator

Lead Sponsor

Chinese PLA General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57,089Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
elderly patients (aged ≥ 65 years)		elderly patients undergo surgeries	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	no intervention	elderly patients (aged ≥ 65 years)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with postoperative acute kidney injury	Postoperative acute kidney injury	within seven days following surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

120 Years

Standard Ages

Older Adult

Study Population

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

Sampling Method

Probability Sample