A Predictive Model for Postoperative Delirium in Kidney Transplant Patients

NCT07078578 | Completed DMC

• 1 other identifier: SXBQEMZK20250701
• Study Type: observational
• Target: 4,800
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to develop and prospectively validate a machine learning-based prediction model for postoperative delirium in kidney transplant recipients, using perioperative clinical data. Delirium is a common and serious postoperative complication that significantly increases morbidity, mortality, and healthcare costs. By analyzing electronic medical records from kidney transplant patients, including preoperative, intraoperative, and postoperative variables, the study seeks to identify high-risk patients and key predictors. Six machine learning models, including XGBoost, LGBM, GBC, LR, ANN, and SVM, will be constructed and evaluated, with a soft voting ensemble classifier used to optimize prediction performance. The goal is to improve early recognition and clinical management of postoperative delirium in kidney transplant patients.

Conditions

Kidney Transplantation; Delirium - Postoperative; Cognitive

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium Within 7 Days After Kidney Transplantation

  Postoperative delirium will be identified within 7 days of surgery through automated extraction and structured analysis of electronic medical record text fields, including progress notes, nursing records, and medication orders for sedatives or anxiolytics. Delirium will be categorized by onset time, severity, treatment, and recovery status.

  7 days after surgery

Study Arms (2)

Delirium Group

Kidney transplant recipients who developed postoperative delirium within 7 days after surgery, identified through EMR text mining and structured data extraction.

Non-Delirium Group

Kidney transplant recipients who did not develop postoperative delirium within 7 days after surgery.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent and adult patients (aged 16 years and older) who underwent kidney transplantation at a single tertiary medical center between January 1, 2016, and May 31, 2025. The study includes retrospective data (2016-2024) for model development and prospective data (2025) for external validation. All included patients were discharged alive and had complete perioperative clinical data available for analysis.

You may qualify if:

• Patients who underwent kidney transplantation at \[Hospital Name, if needed\] between January 1, 2016, and May 31, 2025.
• Age ≥ 18 years at the time of transplantation.
• Discharged alive from the hospital after surgery.
• Complete perioperative clinical data available, including preoperative evaluations, intraoperative records, and postoperative documentation

You may not qualify if:

• Patients with documented pre-existing delirium or major neurocognitive disorder before surgery.
• Simultaneous or multi-organ transplantation (e.g., kidney-pancreas).
• Death within 7 days postoperatively.
• Incomplete or missing key electronic medical records preventing outcome assessment.
• Patients who withdrew consent for use of clinical data for research purposes (for prospective part).

Sponsors & Collaborators

• Hua Zheng: lead

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: January 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share