An Exploratory Study in Three Parts to Determine Sex-Specific Differences in Chronic Kidney Disease Recognition, Progression and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Sex-specific mortality among incident patients undergoing hemodialysis
研究概览
简要总结
This study aims to describe sex specific differences of the hemodialysis population in Austria, to quantify sex specific differences in treatment and outcomes in hospitalized patients with chronic kidney disease and to examine decision making by doctors and patients with regards to hemodialysis initiation.
To adequately serve the needs of these research questions, the study is divided into 3 parts (sub-studies).
- Description and analysis of sex-specific differences in renal replacement therapy in Austria.
- Description and analysis of the competing risks of death versus renal replacement therapy initiation in the chronic kidney disease population by sex.
- Analysis of sex differences in renal replacement therapy initiation decisions, emphasizing patient perception and socio-economic differences.
详细描述
2.1-A Renal Replacement Therapy: Description and analysis of sex-specific differences in hemodialysis patients and the associated male-to-female mortality in Austria
Hypothesis:
There are sex-specific differences in hemodialysis incidence/prevalence and mortality among hemodialysis patients in Austria. There are differences in male-to-female mortality among hemodialysis patients as compared to the general population in Austria.
Methodology:
Data extraction will be performed from the Austrian Dialysis registry which holds complete longitudinal entries of all Austrian hemodialysis patients since 1970 and contains data of all patients undergoing hemodialysis in Austria since the year 1965.Demographic data, laboratory values, clinical characteristics and hemodialysis specific data will be collected for every patient registered in the Austrian Dialysis registry between 1965 and 2015.Male and female population structure and mortality data of the Austrian general population will be retrieved from the ´Statistik Austria´ registry.Additional data of the Austrian general population will be retrieved from the SYSKID project and electronic medical records retrieved in the course of an epidemiologic study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Austrian Dialysis Registry Patient or outpatient
- •Criteria for participation in the survey will be (i) a diagnosis of CKD (eGFR <60 mL/min/1.73 m2) [50% <15]) and (ii) appropriate language skills to fill in a survey.
排除标准
- •Not an Austrian Dialysis Registry Patient or not an outpatient
结局指标
主要结局
Sex-specific mortality among incident patients undergoing hemodialysis
时间窗: Through study completion, the expected average follow-up being 4 years.
"Incident" hemodialysis patients are all those who have entered the Dialysis Registry (they will constitute the study population).
次要结局
未报告次要终点
研究者
Assoc. Prof. Dr. Manfred Hecking, MD PhD
Principal Investigator
Medical University of Vienna