Incremental Dialysis Decision Model Based on Expert-Guided Machine Learning

Completed

• Conditions: End-stage Renal Disease

• Registration Number: NCT06775067
• Lead Sponsor: Huashan Hospital

Brief Summary

This observational prospective study combined clinical expert knowledge with machine learning to develop and validate a predictive model for incremental hemodialysis decision-making. The aim of the predictive model is to assist clinicians in developing individualized incremental dialysis treatment plans to optimize patient outcomes.

Detailed Description

By collecting patients' clinical and biochemical parameters and combining them with experts' judgments of dialysis timing and frequency, the model can dynamically assess patients' risk of needing to increase the frequency of dialysis, thus assisting physicians in formulating individualized incremental dialysis regimens to optimize dialysis outcomes and improve patients' prognosis.

Study Timeline

• Study Start: 2010-04-12
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Status Verified: 2025-01
• Study First Submitted: 2025-01-05
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

1. New hemodialysis patients (Apr 2010-Jun 2024), started within 3 months, including transfers.
2. Age ≥18, stable hemodialysis >6 months.

Exclusion Criteria

1. Incomplete/unreliable data.
2. Twice-weekly palliative dialysis.
3. No baseline urine output or ≤200 mL/24h.
4. Liver disease, heart failure, or severe comorbidities.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number (Proportion) of Participants Who Experience an Incremental Dialysis Event, Assessed Monthly	Baseline and monthly visits from enrollment until incremental dialysis event, death, transfer, or up to 5 years (whichever occurs first)	An incremental dialysis event is defined as an increase in a patient's dialysis frequency (e.g., from 1 session per week to 2 sessions per week, or from 2 to 3 sessions per week, etc.) due to clinical considerations such as decreased residual renal function, fluid overload, or other physician-determined criteria. At each monthly visit (up to 5 years from enrollment), investigators will record whether each participant experiences an incremental event. We will quantify the primary outcome as the number and proportion of participants who transition to a higher dialysis frequency per month, as well as the cumulative incidence over time.

Trial Locations

Locations (1)

Huashan hospital, Fudan university; 🇨🇳 Shanghai, Shanghai, China