NCT00179153已完成2 期
Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- increase in serum albumin
研究概览
简要总结
We propose to identify malnourished chronic kidney dialysis patients through a statewide effort and subsequently treat them based on a protocol (provision of oral nutritional supplementation) over a period of six (6) months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •On CHD dialysis for more than 6 months
- •Adequately dialyzed (Kt/V > 1.0) with a biocompatible hemodialysis membrane. Patients with Kt/V > 1.0 but < 1.4 will be evaluated for etiologies of lower than optimal dialysis dose and every effort will be made to increase the Dialysis dose to 1.4 or above. Patients with all access types will be recruited to the study.
- •Suboptimal nutritional status identified by one of the following criteria:
- •Protein catabolic rate less than 1.0 g/kg/d calculated by three-point urea kinetic modeling on at least 2 occasions over the past 3 months
- •Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of ideal body weight.
- •Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion:
- •Serum albumin less than 4.0 g/dl
- •Serum transferrin concentration less than 250 mg/dl
- •Serum prealbumin concentration less than 32 mg/dl
- •Subjective Global Assessment Score less than 5.
排除标准
- •Intolerance to nutritional supplementation (unable to tolerate any of the nutritional supplements available)
- •Refusal to sign a consent form
- •On nutritional supplementation (IDPN or PO) within 2 weeks of the study initiation.
结局指标
主要结局
increase in serum albumin
时间窗: 6 months
次要结局
未报告次要终点
研究者
Alp Ikizler
Professor
Vanderbilt University
研究点 (2)
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