AI-Driven Prediction of Dialysis Outcome With EHR

April 16, 2025 updated by: Kang Zhang, The Eye Hospital of Wenzhou Medical University

Predicting Clinical Outcomes in Dialysis Patients Using Electronic Health Records: An AI-Based Approach

This is a multi-center, clinical study designed to evaluate the application and effectiveness of an AI-assisted predictive model for outcome of dialysis patients, leveraging multimodal health data.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to develop an AI-assisted model to predict clinical outcomes in dialysis patients, focusing on both primary outcomes (e.g., mortality) and intermediate outcomes (e.g., anemia, blood pressure, nutritional status, and calcium-phosphate metabolism). The study will utilize patients' EHR data, including laboratory test results, medical history, dialysis treatment information, and clinical observations, to predict these health outcomes. The goal is to improve early identification of at-risk patients, enabling better clinical decision-making and personalized care strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • General Hospital of PLA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of dialysis patients from the China Hemodialysis National Network Center, which includes a wide range of patients undergoing hemodialysis treatment at participating hospitals across China. Participants will be selected based on the availability of comprehensive electronic health records (EHR), including medical history, laboratory test results, dialysis treatment details, and clinical observations. The cohort will include both male and female patients, with varying degrees of health status, including those with comorbidities commonly associated with dialysis. The study aims to utilize this diverse group to assess and predict outcomes related to mortality and complications in dialysis patients.

Description

Inclusion Criteria:

  1. Patients who have been undergoing dialysis (either hemodialysis or peritoneal dialysis) for at least 3 months.
  2. Complete and accessible EHR data, including medical history, laboratory test results, dialysis treatment details, and clinical observations.
  3. Participants must provide informed consent for the use of their health data for research purposes.

Exclusion Criteria:

  1. Patients with incomplete or missing critical EHR data, including medical history, laboratory results, dialysis data, or treatment details necessary for the study.
  2. Patients who have been on dialysis for less than 3 months, to ensure stable data for outcome prediction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
High Risk Group
Participants predicted to have a high risk of mortality based on AI-assisted prediction models using their EHR data, including medical history, lab results, dialysis treatment details, and clinical observations.
Other: AI-assisted Predictive Model for Dialysis Outcomes
This study utilizes an AI-assisted predictive model that analyzes multimodal data from electronic health records, including medical history, laboratory results, dialysis treatment details, and clinical observations, to predict outcomes for dialysis patients. The model employs deep learning algorithms to predict mortality risk, intermediate outcomes such as anemia, blood pressure control, nutrition, and calcium-phosphate metabolism, and helps identify early signs of deterioration. The intervention is not a direct treatment or procedure but aims to develop a tool for predicting patient outcomes and optimizing treatment strategies to improve overall health and survival rates for dialysis patients.
Low Risk Group
Participants predicted to have a low risk of mortality based on the AI-assisted prediction model, who will be compared with the high-risk group for evaluating the effectiveness of early intervention strategies.
Other: AI-assisted Predictive Model for Dialysis Outcomes
This study utilizes an AI-assisted predictive model that analyzes multimodal data from electronic health records, including medical history, laboratory results, dialysis treatment details, and clinical observations, to predict outcomes for dialysis patients. The model employs deep learning algorithms to predict mortality risk, intermediate outcomes such as anemia, blood pressure control, nutrition, and calcium-phosphate metabolism, and helps identify early signs of deterioration. The intervention is not a direct treatment or procedure but aims to develop a tool for predicting patient outcomes and optimizing treatment strategies to improve overall health and survival rates for dialysis patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality Prediction Accuracy
Time Frame: 1 year
The ability of the AI-assisted predictive model to accurately predict the risk of mortality in dialysis patients. Prediction accuracy will be assessed using the Area Under the Curve (AUC), F1 score, and sensitivity/specificity. The model will be evaluated by comparing the predicted mortality risk with actual outcomes (i.e., whether patients survived or passed away during the study period).
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications Prediction Accuracy
Time Frame: 1 year
The accuracy of the AI-assisted predictive model in forecasting complications commonly experienced by dialysis patients, including anemia, uncontrolled blood pressure, poor nutritional status, and abnormalities in calcium-phosphate metabolism. The model's performance will be assessed using metrics such as AUC, F1 score, and accuracy by comparing predicted values to actual clinical outcomes, such as lab results, clinical diagnoses, and patient health status.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Eye Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dialysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings