NCT06146829

Brief Summary

Acute kidney injury (AKI) is a common surgical complication characterized by a rapid decline in renal function. Patients with AKI are at an increased risk of developing chronic kidney disease and end-stage renal disease, which has been associated with an increased risk of morbidity, mortality and financial burdens. Identifying high-risk patients for postoperative AKI early can facilitate the development of preventive and therapeutic management strategies, and prediction models can be helpful in this regard. The goal of this retrospective study is to develop prediction models for postoperative AKI in noncardiac surgery using machine learning algorithms, and to simplify the models by including only preoperative variables or only important predictors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88,367

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 27, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

18 days

First QC Date

November 19, 2023

Last Update Submit

April 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative acute kidney injury

    In accordance with the KDIGO creatinine criteria: a serum creatinine increases of 26.5 mmol/L within 48 hours or 1.5 times baseline within 7 days after surgery.

    Within 7 days after surgery

Interventions

no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent noncardiac surgical procedures at Tongji hospital between July 2018 and October 2022 were included.

You may qualify if:

  • Adult patients (age ≥ 18 years) who had a serum creatinine measurement within 10 days before surgery and at least one measurement within 7 days after surgery.
  • Eligible surgeries encompassed general, thoracic, orthopedic, obstetric, gynecology, and neurosurgery procedures lasting longer than 1 hour

You may not qualify if:

  • Patients with concurrent cardiac, vascular, urological, or transplant surgeries.
  • Patients with an American Society of Anesthesiologists (ASA) physical status V.
  • Patients with end-stage renal disease (i.e., a glomerular filtration rate \[eGFR\] of 15 mL/min/1.73 m² or receiving hemodialysis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rao Sun

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

  • Sun R, Li S, Wei Y, Hu L, Xu Q, Zhan G, Yan X, He Y, Wang Y, Li X, Luo A, Zhou Z. Development of interpretable machine learning models for prediction of acute kidney injury after noncardiac surgery: a retrospective cohort study. Int J Surg. 2024 May 1;110(5):2950-2962. doi: 10.1097/JS9.0000000000001237.

Study Officials

  • Rao Sun

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

November 19, 2023

First Posted

November 27, 2023

Study Start

November 27, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations