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临床试验/NCT02023528
NCT02023528已完成不适用

Dialysis Registry in Utah

University of Utah1 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
243
试验地点
1
主要终点
Demographics, co-morbid conditions and characteristics of dialysis patients

研究概览

简要总结

Based on the Medicare data, the 5-year survival of dialysis patients is only 39%. This is lower than that of stage IIIB breast cancer (54% 5-year survival). The annual mortality of dialysis patients is ~ 23% compared to <0.1% in the United States general population. Even kidney transplant recipients have a substantially higher mortality (~7%) compared to the general population. Consequently, the life-expectancy of dialysis and transplant populations is much lower than that of the general population. Cardiovascular events are the leading cause of death in dialysis patients and malnutrition is also a strong risk factor for death. The current proposal is to develop a prospective registry of incident dialysis patients at the University of Utah dialysis program to examine cardiovascular and nutritional factors in dialysis patients. This registry will include clinical and administrative data. In addition, blood samples will be stored for future analyses.

详细描述

Design:

This is a prospective, observational study of patients in the University of Utah dialysis program.

Study Procedures:

Patients new to dialysis at the University of Utah dialysis program will be approached to determine whether they want to participate in the registry. If they are interested, the study purpose and procedures will be explained and informed consent obtained. Participants will be asked to complete a brief questionnaire on demographics (age, gender, race, education), co-morbid conditions (diabetes mellitus, congestive heart failure, hypertension, chronic lung disease, malignancies, coronary artery disease, cerebrovascular disease and peripheral vascular disease), physical activity level, cognitive function and sleep patterns. Height, weight, and waist circumference will be measured. Annual follow up visits will be conducted with each patient until the 5th annual follow-up, death, transplantation or loss to follow-up. During these visits, participants will complete questionnaires on physical activity level, cognitive function and sleep patterns. Height, weight, and waist circumference will be measured. Thirty milliliters (ml) of blood will also be drawn.

Relevant Dialysis data (cause and duration of kidney disease, duration of dialytic therapy, duration and frequency of dialysis sessions, type of dialyzer used, type of vascular access), medications (erythropoietin dose and route of administration, iron supplements), laboratory markers (hemoglobin, serum calcium, serum intact parathyroid hormone, serum phosphorous, white blood cell count with differential neutrophil and lymphocyte counts and urea reduction rate) will be obtained from the electronic medical records.

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

入选标准

  • Must be above the age of
  • Consenting to participate in the registry.

排除标准

  • <18 years of age

结局指标

主要结局

Demographics, co-morbid conditions and characteristics of dialysis patients

时间窗: baseline

The objective is to develop a registry of incident dialysis patients at the University of Utah dialysis program

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

Srinvasan Beddhu

MD

University of Utah

研究点 (1)

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