- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06689059
Research on Multimodal Multi-objective Integrated Machine Algorithm for Hip Replacement Surgery
HoPreM Platform: Efficient Multimodal Multi-Task Prediction of Perioperative Events Following Hip Replacement Surgery
Purpose:
The aim of this study is to develop the Holistic Predictive Multi-Tasking Platform for Clinical Data Analysis (HoPreM) to accurately predict perioperative events following hip replacement surgery by integrating various types of data, including demographic, surgical, medical history, and laboratory information. The events targeted for prediction include acute kidney injury (AKI), blood transfusion requirements, 48-hour postoperative discharge (48hPOD), Intensive Care Unit (ICU) transfer, and length of hospital stay (LOS).
Key Questions:
Can the HoPreM platform reduce the risk of complications after hip replacement surgery? How accurate is the platform in predicting the specified perioperative events?
Participants:
Participants will include patients undergoing hip replacement surgery, aged 18 and above, with less than 10% missing values in their medical records. The collected data will be used to train and test the predictive models of the HoPreM platform.
Study Procedures:
Patient data will be collected from Xi'an Honghui Hospital, including creatinine values recorded before and after surgery.
The HoPreM platform will process multimodal data, including demographic, surgical, medical history, and laboratory test data.
Various ensemble learning algorithms (including XGBoost, random forest, LightGBM, and CatBoost) will be applied to predict different perioperative outcomes.
Expected Outcomes:
The HoPreM platform is expected to demonstrate its capability in predicting complications after hip replacement surgery, particularly acute kidney injury and blood transfusion requirements. Through SHAP value analysis, the study aims to reveal relationships between features and clinical outcomes, enhancing the model's interpretability and clinical utility.
Contact Information:
For any questions about this study or for more information, please contact the research team.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
This study includes adult patients who have undergone hip replacement surgery at Xi'an Honghui Hospital. The study population is characterized by a diverse range of gender, age, and medical history, including patients with hypertension, diabetes, and other comorbidities. The inclusion criteria are:
Age 18 years or older Missing values in medical records less than 10% Logically consistent medical records Availability of both preoperative and postoperative creatinine values The goal is to create a comprehensive dataset that represents the typical demographic of patients seen in clinical practice for hip replacement surgery.
Description
Inclusion Criteria:
- Patients who have undergone hip replacement surgery
- Age 18 years or older
- Missing values in medical records less than 10%
- Logically consistent medical records
- Availability of both preoperative and postoperative creatinine values
Exclusion Criteria:
- Non-hip replacement surgery patients (patients who did not undergo hip replacement surgery)
- Age less than 18 years
- Missing values greater than 10% in medical records
- Logical inconsistencies in the medical record
- No available preoperative or postoperative creatinine values
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hip Replacement Cohort
This cohort includes patients undergoing hip replacement surgery.
The HoPreM platform is used for multi-task predictive analysis of perioperative complications, including AKI, blood transfusion requirements, postoperative discharge within 48 hours, ICU transfer, and length of hospital stay (LOS).
|
This study utilizes a multimodal data integration and multi-task learning approach to predict perioperative events after hip replacement surgery.
By combining various data types, including demographics, surgical details, medical history, and lab results, the model enhances prediction accuracy for outcomes like AKI, blood transfusion needs, and ICU transfers.
The use of ensemble learning algorithms such as CatBoost optimizes the platform's performance, offering a unique method for clinical decision support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Transfusion Requirements
Time Frame: From post-surgery Day 1 until discharge, up to a maximum of 40 days, assessed based on whether a blood transfusion was recorded during the hospital stay.
|
To evaluate the need for blood transfusion postoperatively.
|
From post-surgery Day 1 until discharge, up to a maximum of 40 days, assessed based on whether a blood transfusion was recorded during the hospital stay.
|
|
48-Hour Postoperative Discharge
Time Frame: Within 48 hours post-surgery, assessed based on whether the patient was discharged from the hospital within this 48-hour period.
|
This outcome measure assesses whether the patient was discharged from the hospital within 48 hours following surgery.
|
Within 48 hours post-surgery, assessed based on whether the patient was discharged from the hospital within this 48-hour period.
|
|
ICU Transfer
Time Frame: From post-surgery Day 1 until discharge, up to a maximum of 40 days, assessed based on whether an ICU transfer occurred during the hospital stay.
|
This outcome measure records whether the patient was transferred to the Intensive Care Unit (ICU) at any point during the hospital stay from post-surgery Day 1 until discharge, with a maximum observation period of 40 days.
|
From post-surgery Day 1 until discharge, up to a maximum of 40 days, assessed based on whether an ICU transfer occurred during the hospital stay.
|
|
Length of Hospital Stay
Time Frame: Total duration of hospital stay from admission to discharge, with a maximum observation period of 40 days.
|
This outcome measure calculates the total number of days the patient spends in the hospital from the time of admission until discharge, up to a maximum of 40 days.
|
Total duration of hospital stay from admission to discharge, with a maximum observation period of 40 days.
|
|
Acute Kidney Injury (AKI) Incidence
Time Frame: From Day 1 to Day 7 post-surgery.
|
AKI incidence will be assessed daily by comparing serum creatinine levels with the preoperative baseline.
AKI incidence is determined by a ≥0.3 mg/dL increase in creatinine within 48 hours or a ≥50% increase within 7 days from baseline.
|
From Day 1 to Day 7 post-surgery.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jingkun Liu, Honghui hospital, Xi'an Jiaotong University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Xi'anHongHuiH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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