NCT00179205终止2 期
Complementary Intradialytic Nutritional Supplementation in Dialysis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- increase in serum albumin
研究概览
简要总结
In this study, the investigators hypothesize that long-term administration of adequate intradialytic oral nutritional supplementation will increase visceral protein concentrations and somatic protein stores in malnourished chronic hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 hemodialysis for more than 6 months
- •Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V > 1.2)
- •Suboptimal nutritional status identified by:
- •Serum albumin less than or equal to 3.90 g/dl and one of the three following criteria:
- •Protein catabolic rate less than 0.95 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months
- •Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight over the past 6 months and/or patients who are less than 90% of standard body weight
- •Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements over the consecutive two months prior to inclusion:
- •Serum transferrin concentration less than 225 mg/dl
- •Serum prealbumin concentration less than 32 mg/dl
排除标准
- •Active auto-immune, inflammatory or infectious disease
- •Documented malignancy within the last 12 months
- •Patients on unusual dietary restrictions
- •Life-expectancy less than 6 months
- •Inability to tolerate nutritional supplements
研究组 & 干预措施
1
Active Comparator
干预措施: Nepro nutritional supplement (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
increase in serum albumin
时间窗: 6 months
次要结局
- increase in lean body mass(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Improvement of nutritional state by intradialytical parenteral nutrition in children treated with haemodialysisMalnutrition/Haemodialysis pediatric patientsNutritional, Metabolic, EndocrineISRCTN59440030Baxter Healthcare Corporation (USA)20
招募中
不适用
Effect of enteral protein supplements on malnourished hemodialysis patientsKidney DiseasePACTR202209728463176Mariam Shaker Nazeh70
招募中
不适用
The effect of intradialytic parenteral nutrition on nutritional status and quality of life in hemodialysis patientsdialysemalnutritionsarcopenia1000301810038430NL-OMON52472Erasmus MC, Universitair Medisch Centrum Rotterdam166
招募中
不适用
Intra Dialytic Parenteral Nutrition and Nutritional Gap Nutritional Gap Identified by Indirect CalorimetryChronic Kidney DiseasesProtein Energy WastingNCT05568914Universitair Ziekenhuis Brussel20
进行中（未招募）
不适用
Impact of IDPN on Nutrition Markers in Patients Receiving ICHDEnd-stage Renal DiseaseProtein MalnutritionNCT05439174Patient Care America1,200