Validity and Reproducibility of OSND (Objective Score of Nutrition on Dialysis) as a Nutritional Marker in End-stage Renal Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- All cause morbidity and mortality
研究概览
简要总结
This prospective observational study is planned to validate OSND against the prospective morbidity and mortality in chronic hemodialysis patients and to examine the hypothesis that OSND risk stratification of chronic HD patients is useful in predicting outcomes and better than its component alone or in diverse combinations. The investigators specific aim is to validate OSND in chronic HD patients by comparing it with conventional measures of nutritional state, including blood tests, anthropometry, MIS, GNRI, bioelectric impedance analysis and several measures of clinical outcome including prospective mortality and hospitalization.
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
- 否
入选标准
- •Male or female, age > 18 years, in chronic hemodialysis treatment at least 3 months
- •Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V > 1.2 and/or hemodialysis performed 4 hours 3 times weekly
- •Patients with normal hydration status (edema-free), with no neuroid-muscular diseases
- •Informed consent obtained before any trial-related activities
排除标准
- •Patients with edema, pleural effusion or ascites at their initial assessment
- •Patients with active malignant disease or liver cirrhosis
- •Patients with neuroid-muscular diseases
- •Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent)
- •Patients treated with immunosuppressive agents
- •Patients suffering from
- •Acute vasculitis
- •Severe systemic infections
- •Heart failure (NYHA class III-IV)
结局指标
主要结局
All cause morbidity and mortality
时间窗: during 2 years of observation
* Associations of OSND with: * Morbidity: Days at hospital (over night stay). Measured from baseline to end of study * Morbidity: Number of sick days during the study period * Morbidity: Number of visits to health care professionals other than hospitals * Mortality: From baseline visit to end of study * Interobserver reproducibility of OSND.
次要结局
- All cause morbidity and mortality(2 years)