CompletedNot Applicable

Research and Validation of a Big Data-Driven Intelligent Decision-Making System for Hemodialysis

China778 participantsStarted 2011-01-01

Plain-language summary

Objectives and Scope:This observational study aims to leverage real-world data from Huashan Hospital to develop an AI-driven intelligent decision-making system for assessing dialysis adequacy in maintenance hemodialysis (MHD) patients, and to analyze early warning factors contributing to inadequate dialysis. Core Research Question:Can an AI-based early warning and diagnostic model, built on multidimensional big data, identify the risk of inadequate hemodialysis at an ultra-early stage and accurately diagnose composite complications such as cardiovascular and cerebrovascular diseases? Methodology:The study will conduct a retrospective analysis of adult MHD patients treated at Huashan Hospital between January 2011 and September 2025. The dataset encompasses multidimensional variables, including sociodemographics, treatment parameters, laboratory indicators, metabolomics, and physical functions. Utilizing Dynamic Network Biomarkers (DNB) technology to screen for early warning markers, combined with artificial intelligence algorithms such as Neural Networks and Support Vector Machines (SVM), the study will construct two primary models: "Ultra-early Warning" and "Disease State Diagnosis." These models are designed to provide clinical decision support for precise interventions.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing long-term maintenance hemodialysis with a dialysis vintage of at least 3 months. * Aged between 18 and 90 years. * Possess relatively comprehensive hemodialysis records maintained within this center. Exclusion Criteria: * Patients with significantly incomplete dialysis-related data. * Patients with poor compliance during dialysis or those receiving palliative dialysis. * Other conditions deemed unsuitable by the investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiovascular and Cerebrovascular Diseases (CCVD)

Timeframe: 15 years (From January 2011 to September 2025)

Trial details

NCT IDNCT07466329

SponsorHuashan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More ESRD (End Stage Renal Disease) trials