Incremental Dialysis Decision Model Based on Expert-Guided Machine Learning

NCT ID: NCT06775067

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-12

Study Completion Date

2024-06-28

Brief Summary

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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

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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.

Conditions

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End-stage Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Huashan Hospital Hemodialysis Cohort

This is a single-center prospective cohort study that included 175 patients with end-stage renal disease (ESKD) who received maintenance hemodialysis at the hemodialysis center of Huashan Hospital from April 2010 to June 2024. The ESKD patient population was comprised of 175 cases in total. All patients retained some residual kidney function (RKF), and their dialysis records and regular laboratory test results were integrated as input features for the machine learning model. The primary objective of the model was twofold: first, to integrate expert knowledge with machine learning to predict when a switch from lower frequency incremental dialysis (I-HD) to higher frequency dialysis should be made; and second, to identify key variables affecting the risk of adverse outcomes over a two-year period.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Jing

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jing Chen

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

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Huashan hospital, Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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KY2019-585

Identifier Type: -

Identifier Source: org_study_id

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