Validation of Bioelectrical Impedance Vector Analysis for Nutritional Assessment in Patients With Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Changes in nutritional status
研究概览
简要总结
Despite the importance of nutritional status in patient's outcome, there is no gold standard for nutritional assessment. Traditional techniques used in healthy subjects to assess nutritional status cannot be used in cirrhotic patients due especially to ascites and peripheral edema, and altered rates of biochemical markers due to liver failure.
Bioelectrical impedance vector analysis has emerged as a useful method to assess body composition and nutritional status especially in patients at the extremes of body weight (fluid overload, excess of adipose tissue, etc.).
With previous results from our research group, BIVA showed to be useful for evaluating cirrhotic patients.
The aim of this study is to validate our previous results and validate BIVA for nutritional assessment in patients with liver cirrhosis
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnose of liver cirrhosis by two or more of the following criteria:
- •Albumin < 3.4 g/dL
- •INR ≥ 1.3
- •Total bilirubin ≥ 2 mg/dL
- •Portal hypertension (esophageal varices, splenomegaly, ascites, etc.)
- •Liver biopsy
- •Ambulatory patients
排除标准
- •Personal history of surgery in the last four weeks
- •Thyroid disorders without replacement therapy
- •Pregnancy
- •Active alcoholism with alcohol ingest in the previous 6 months.
- •Acute or chronic renal failure
- •Hepatic or renal transplant
结局指标
主要结局
Changes in nutritional status
时间窗: At the time of inclusion, every six months up to 36 months
It will be assessed by bioelectrical impedance vector analysis
次要结局
未报告次要终点
研究者
ALDO TORRE DELGADILLO
M.D., M.Sc.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran