A Predictive Model for Postoperative Delirium in Kidney Transplant Patients

NCT ID: NCT07078578

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2025-02-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Delirium Group

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

No interventions assigned to this group

Non-Delirium Group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hua Zheng

OTHER

Sponsor Role: lead

Responsible Party

Hua Zheng

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

SXBQEMZK20250701

Identifier Type: -

Identifier Source: org_study_id