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临床试验/NCT06775067
NCT06775067已完成不适用

Machine Learning Based on Expert Knowledge to Build and Validate a Decision Model for Incremental Dialysis

Huashan Hospital1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2010年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
175
试验地点
1
主要终点
Number (Proportion) of Participants Who Experience an Incremental Dialysis Event, Assessed Monthly

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

结局指标

主要结局

Number (Proportion) of Participants Who Experience an Incremental Dialysis Event, Assessed Monthly

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Jing

Professor

Huashan Hospital

研究点 (1)

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