Kidney TransplantationNCT07078578
A Predictive Model for Postoperative Delirium in Kidney Transplant Patients
An observational study of Kidney Transplantation and Delirium - Postoperative, run by Hua Zheng.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Kidney Transplantation, Delirium - Postoperative, Cognitive
- How many people
- 4,800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
About this study
Official title: Construction of a Machine Learning Prediction Model for Postoperative Delirium in Kidney Transplant Patients Based on Clinical Data
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
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2016
- Primary completion1 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Zheng, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078578
- Sponsor's protocol ID
- SXBQEMZK20250701
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset includes sensitive clinical information from kidney transplant patients. IPD will not be shared due to patient privacy concerns and institutional data use restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Machine Learning Prediction Model for Postoperative Delirium in Kidney Transplant Patients Based on Clinical Data
- ClinicalTrials.gov ID
- NCT07078578
- Acronym / sponsor ID
- SXBQEMZK20250701
- Conditions
- Kidney Transplantation, Delirium - Postoperative, Cognitive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,800 participants (actual)
- Lead sponsor
- Hua ZhengUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Postoperative Delirium Within 7 Days After Kidney Transplantation
Time frame: 7 days after surgery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No. The dataset includes sensitive clinical information from kidney transplant patients. IPD will not be shared due to patient privacy concerns and institutional data use restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Delirium - Postoperative, run by Hua Zheng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium Within 7 Days After Kidney Transplantation (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.