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临床试验/NCT02887391
NCT02887391Unknown不适用

Comparing Nutritional Status of In-centre Nocturnal Hemodialysis Patients to Conventional Hemodialysis Patients: A Prospective Cohort Study

University of Calgary1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Malnutrition Inflammation Score (MIS)

研究概览

简要总结

Although hemodialysis is life-saving, unfortunately, people on dialysis often have declining health, quality of life as well as poor nutritional status. Hemodialysis patients must follow a very restrictive diet, and many patients do not eat well and usually report poor appetites. A new approach to dialysis is being used in some hospitals in Alberta and elsewhere, called in-centre nocturnal hemodialysis. This in-centre nocturnal dialysis allows people to receive their dialysis at a hospital or clinic while they sleep. Since this in-centre nocturnal dialysis gives people 8-hour hemodialysis treatment 3 times per week (24 hours of dialysis per week) the patients have better removal of the waste products from their bodies than conventional hemodialysis (an average of 12 hours per week). Also of importance, when using in-centre nocturnal dialysis, people will have more time during the day to work, spend with family, as well as have time to shop for food, to cook and even to eat, which in turn will likely result in improvement in the quality of their lives. This study will follow 10 patients on conventional dialysis and 10 patients on in-centre nocturnal dialysis for 6 months and compare their food intake, muscle mass, weight, body mass index (BMI) and nutrition-related lab tests. The purpose of this study is to determine whether there is an improvement in the nutritional status of the in-centre nocturnal hemodialysis patients compared to the nutritional status of conventional hemodialysis patients.

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

  • >18 years of age
  • referred to the in-centre nocturnal hemodialysis program
  • medically stable
  • undergo hemodialysis three to four times per week for a minimum of three hours per week
  • able to provide written, informed consent

排除标准

  • younger than 18 years old
  • have a current diagnosis with palliative status (e.g. cancer) or have active disease
  • have had a prolonged hospitalization (>3 weeks) within the previous 3 months

结局指标

主要结局

Malnutrition Inflammation Score (MIS)

时间窗: Baseline & 6 months

A survey/tool that uses both subjective global assessment and objective laboratory measures to evaluate nutritional status. Change from baseline MIS at 6 months will be measured in both groups.

次要结局

  • Interdialytic Weight Gain(Baseline & 6 months)
  • Triceps Skinfold Thickness(Baseline & 6 months)
  • Dietary Intake(Baseline & 6 months)
  • Appetite(Baseline & 6 months)
  • Handgrip Strength(Baseline & 6 months)
  • Bio-electrical Impedance(Baseline & 6 months)
  • Mid Arm (Muscle) Circumference(Baseline & 6 months)
  • Quality of Life(Baseline & 6 months)
  • C-reactive protein (CRP)(Baseline & 6 months)
  • Total iron binding capacity (TIBC)(Baseline & 6 months)
  • Body Mass Index (BMI)(Baseline & 6 months)
  • Phosphate Binders(Baseline & 6 months)
  • Serum Albumin(Baseline & 6 months)

研究者

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

Dr Jennifer MacRae

Associate Professor Medicine

University of Calgary

研究点 (1)

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