Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 204
- 主要终点
- mortality
研究概览
简要总结
IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score
详细描述
IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score.
Patient eligibility: adult patients ≤ 82 y with HD vintage > 6 mo. and 2 of the following malnutrition criteria: BMI ≤ 20 kg/m2, BW loss/6 mo. ≥ 10%, serum albumin ≤ 35 g/L, prealbumin ≤ 300 mg/L.
Recruitment: patients in 38 HD units from January 2001 to December 2002 Study protocol. Patients are randomized into 2 groups: IDPN group, given IDPN during one year, and control group. For ethical reasons, the 2 groups are given oral supplementation during the same period.
Follow-up: two years after start of nutritional therapy. Study end: December 31, 2004. Final results will be available in early 2005.
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 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 82 years
- •hemodialysis vintage more than 6 months
- •two of the following markers of malnutrition:
- •body mass index (BMI) <= 20 kg/m2
- •body weight loss within 6 months >= 10 percent
- •serum albumin <= 35 g/L
- •prealbumin <= 300 mg/L
排除标准
- •weekly dialysis time < 12 h
- •urea Kt/V index < 1.2
- •serum albumin > 38 g/L
- •prealbumin > 330 mg/L
- •hypertriglyceridemia > 2.5 mmol/L
- •associated comorbidities compromising the one-year survival
- •treatment by oral, enteral or parenteral feeding during the last 3 months
- •hospitalization at time of randomization
结局指标
主要结局
mortality
次要结局
- hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin