NCT05507268

Brief Summary

Postoperative acute kidney injury is associated increased risk of morbidity and mortality. Older patients are at high risk of developing postoperative acute kidney injury. However, the incidence and associations of postoperative acute kidney injury in older patients are not well understood. This study aims to develop and validate a predictive nomogram for postoperative acute kidney injury in older patients undergoing noncardiac surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

August 17, 2022

Last Update Submit

August 17, 2022

Conditions

Postoperative Acute Kidney Injury

Keywords

prediction modelnomogramoldernoncardiac surgery

Outcome Measures

Primary Outcomes (1)

  • acute kidney injury

    an absolute increase in serum creatinine of 0.3 mg/dl within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery

    7 days after surgery

Study Arms (1)

older patients undergoing noncardiac surgery

older patients (aged ≥65 years) scheduled for noncardiac surgery

Other: no intervention

Interventions

no interventionOTHER

no intervention

older patients undergoing noncardiac surgery

Eligibility Criteria

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

Older patients (aged ≥ 65 years) undergoing noncardiac surgery from 2012-2019

You may qualify if:

  • Patients aged 65 years and older

You may not qualify if:

  • Emergency operation
  • Cardiac surgery
  • Incomplete data
  • Incomplete data
  • Local anesthesia
  • Preoperative renal failure or requirement for dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

  • Weidong Mi, PhD

    The First Medical Center of Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weidong Mi, PhD

CONTACT

8613381082966wwdd1962@163.com

Yao Yu, PhD

CONTACT

861850108897518501088975@163.com

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

August 17, 2022

First Posted

August 18, 2022

Study Start

April 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Locations

CN(1)