Development of a Mortality Prediction Model for Patients Receiving Maintenance Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Cardiovascular Mortality
研究概览
简要总结
This prospective, single-center observational cohort study evaluates cardiovascular mortality risk in adults receiving maintenance hemodialysis. During the first year after enrollment, four scheduled assessments are used to characterize demographic factors, dialysis treatment, medication use, routine laboratory measures, and the proportion of serum phosphate measurements within the protocol-defined target range. Participants are subsequently followed for cardiovascular mortality. The study evaluates factors associated with serum phosphate target achievement and develops a cardiovascular mortality prediction model in the overall cohort, with a prespecified subgroup analysis among participants who undergo parathyroidectomy. No treatment or procedure is assigned by the study investigators.
详细描述
This is a prospective observational cohort study conducted at the Hemodialysis Center of Huashan Hospital, Fudan University. Adults aged 18 to 85 years who have received maintenance hemodialysis for at least 3 months and meet the eligibility criteria are enrolled after providing written informed consent.
During the first year after enrollment, four scheduled assessments are performed. Data collected include demographic and clinical characteristics, dialysis treatment parameters, medication use, complete blood count, routine biochemical measurements, immunologic measurements, and other clinically relevant indicators. The principal exposure is the one-year serum phosphate target achievement rate, defined as the number of evaluable serum phosphate measurements within the protocol-defined target range divided by the total number of evaluable scheduled measurements during the one-year assessment period.
Following the one-year exposure-assessment period, participants are followed for cardiovascular mortality for up to 5 years. The primary objective is to evaluate the association between the one-year serum phosphate target achievement rate and cardiovascular mortality and to develop a cardiovascular mortality prediction model. Secondary objectives include identifying factors associated with serum phosphate target achievement and developing a mortality prediction model in the prespecified subgroup of participants who undergo parathyroidectomy as part of routine clinical care.
Descriptive analyses and appropriate parametric or nonparametric tests are used to summarize and compare participant characteristics. Multivariable regression is used to evaluate factors associated with serum phosphate target achievement. Cox proportional hazards regression and prespecified statistical or machine-learning methods are used to evaluate cardiovascular mortality risk and develop prognostic models. All statistical tests are two-sided with an alpha level of 0.05. No study-specific treatment is assigned, and clinical management is determined independently by the treating physicians.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receipt of maintenance hemodialysis for at least 3 months.
- •Adequate ability to understand the study and communicate with the investigators.
- •Provision of written informed consent.
排除标准
- •Age younger than 18 years or older than 85 years.
- •Pregnancy or plans to become pregnant during the relevant study period.
- •Participation in another clinical research study within the preceding month.
- •Presence of a disease or clinical condition considered likely to materially affect serum phosphate concentrations.
- •Any other condition that, in the investigator's judgment, makes participation inappropriate.
研究组 & 干预措施
Maintenance Hemodialysis Cohort
Adults receiving maintenance hemodialysis for at least 3 months at Huashan Hospital are observed without a study-assigned intervention. Demographic, clinical, medication, laboratory, and dialysis-treatment data are recorded during a one-year assessment period, followed by longitudinal ascertainment of cardiovascular mortality. Participants may be classified according to serum phosphate target achievement and parathyroidectomy status for prespecified analyses.
干预措施: One-Year Serum Phosphate Target Achievement Rate (Other)
Maintenance Hemodialysis Cohort
Adults receiving maintenance hemodialysis for at least 3 months at Huashan Hospital are observed without a study-assigned intervention. Demographic, clinical, medication, laboratory, and dialysis-treatment data are recorded during a one-year assessment period, followed by longitudinal ascertainment of cardiovascular mortality. Participants may be classified according to serum phosphate target achievement and parathyroidectomy status for prespecified analyses.
干预措施: Parathyroidectomy (Procedure)
结局指标
主要结局
Cardiovascular Mortality
时间窗: Up to 5 years after completion of the 1-year exposure-assessment period
Occurrence and date of death attributed to cardiovascular disease during follow-up, ascertained through study follow-up and available clinical or death records.
次要结局
- One-Year Serum Phosphate Target Achievement Rate(During the first year after enrollment)
- Mortality in the Parathyroidectomy Subgroup(Up to 5 years after completion of the 1-year exposure-assessment period)