DaVita Assessment of Nutritional Supplement Effects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The primary outcome measure of this study is albumin level, both mean albumin level and percentage of patients achieving an albumin level of >3.8 and > 4.0
研究概览
简要总结
This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients will be randomized to either receive one can of Nepro with Carb Steady at each dialysis treatment for 6 months or to receive the standard of care counseling for malnutrition. The primary hypothesis is that hypoalbuminemic maintenance hemodialysis patients will demonstrate an improvement in albumin levels with oral nutritional supplement provided in-center thrice weekly in addition to standard of care as compared to malnourished maintenance hemodialysis patients provided standard of care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient is at least 18 years of age
- •Patient has been on hemodialysis >6 months at the time of study entry
- •Patient dialyzes three times a week
- •Patient agrees to try ONS for the 6 month study period.
- •Patient has demonstrated an albumin <3.5 g/dL on last available lab drawn in dialysis facility
- •Patient is adequately dialyzed with a Kt/V > 1.4 at the most recent lab draw
- •Patient is capable of reading and comprehending Informed Consent Form and provides written informed consent
排除标准
- •Peritoneal dialysis
- •Dysphagia
- •Aspiration risk
- •Difficulty swallowing
- •History of symptomatic intolerance to food or liquid consumption during dialysis treatments
- •Terminal illnesses with life expectancy <6 months, e.g. stage IV cancer or full blown AIDS
- •Concurrent appetite stimulants
- •Use of IDPN in last 3 months
- •Inability to follow and to comply with the instructions and guidelines
- •Severe liver disease defined as most recent SGOT > 78
- •Active malignancy (other than skin)
- •Major surgery within previous 6 months or anticipated during the 90-day study period
- •Females who are pregnant or are breast-feeding
- •Considered clinically unstable by the treating nephrologists
- •Noncompliance with dialysis treatments ( Missed > 2 treatments in prior month due to noncompliance)
- •Extended or frequent hospitalizations defined as hospitalization of longer than 15 days with discharge within the last 30 days or greater than 3 admissions within the last 30 days
- •Regular supplement use defined as consumption of > 7 servings of a commercially available kcal/ protein supplement in the prior month
- •Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
结局指标
主要结局
The primary outcome measure of this study is albumin level, both mean albumin level and percentage of patients achieving an albumin level of >3.8 and > 4.0
时间窗: Monthly for the 6 month study period
次要结局
- Malnutrition Inflammation Score (MIS)(Month 0 and Month 6)
- Body Mass Index (BMI)(Monthly for the 6 month study period)
- Estimated Dry Weight (EDW)(Monthy for the 6 monthly study period)
- Prealbumin level(Months 0,2,4,&6)
- C-Reactive protein level(Month 0,3 &6)