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临床试验/NCT03400046
NCT03400046已完成不适用

The Correlation Between Nutritional Support Regimens and Muscle Mass in Patients With Chronic Intestinal Failure

Jinling Hospital, China0 个研究点目标入组 223 人开始时间: 2013年9月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
223
主要终点
Body composition

研究概览

简要总结

Patients who are suffer from CIF often develop muscle wasting because of hypercatabolism.The relationship between different nutrition support formulas and lean body mass is still unclear. The purpose of this study is to investigate the relationship between nutrition support and muscle mass and attempt to find the nutrients which will benefit lean body mass in patients with CIF.

详细描述

Chronic intestinal failure (CIF) is defined as the malabsorption and nutrients deficiency mainly caused by severe gastrointestinal benign diseases such as intestinal fistula, short bowel, and mechanical obstruction and some malignant diseases such as end-stage intra-abdominal or pelvic cancers . CIF is one of the rarest of organ failures all over the world and patients suffer from CIF often requires a prolonged time to recover . Hypercatabolism caused by diseases stress, inflammation and reduced nutrient intake indicates that patients with CIF need long-term nutritional support .

Patients who are suffer from CIF often develop muscle wasting because of hypercatabolism. Moreover, studies showed that low muscle mass and muscle wasting during critical illness are associated with poor clinical outcomes and hampered rehabilitation. Except Resistance training, sufficient nutrients supplement also play important roles in maintaining the skeletal muscle mass. Guidelines recommended that nutritional support regimens in patients should be individualized and adjusted over time based on formal nutritional assessment . However, almost all guidelines only recommended the total energy and protein requirements based on the results of basal metabolic rate (BMR) and nitrogen balance rather than the lean body mass . The relationship between different nutrition support formulas and lean body mass is still unclear.

The purpose of this study is to investigate the relationship between nutrition support and muscle mass and attempt to find the nutrients which will benefit lean body mass in patients with CIF.

All adult CIF patients (age ≥18 years) receiving nutrition support were included. The exclusion criteria were hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin >3 mg/dL), renal insufficiency (serum creatinine [Scr] >1.5 mg/dL), acute or life-threatening diseases (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and pregnant or breast-feeding women. The study was approved by the ethics committee of Jinling Hospital, Medical School of Nanjing University.

The lean body mass include soft lean mass (SLM), skeletal muscle mass (SMM) and fat free mass (FFM) which were measured and recorded by body composition analyzer (InBody S10, Biospace) at the time of admission and discharge respectively.The deviation of lean body mass was calculated by the difference between admission and discharge, and then symbolized as ∆SLM, ∆SMM and ∆FFM. Basic and nutritional information of CIF patients was measured weekly after hospital admission, including age, sex, BMI, NRS-2002 score, SGA grade, etiology of malnutrition, daily energy & protein intake via EN & PN.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult CIF patients (age ≥18 years) receiving nutrition support were included

排除标准

  • Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin >3 mg/dL), renal insufficiency (serum creatinine [Scr] >1.5 mg/dL), acute or life-threatening diseases (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and pregnant or breast-feeding women

结局指标

主要结局

Body composition

时间窗: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.

soft lean mass/skeletal muscle mass/fat free mass

次要结局

未报告次要终点

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Xinying

Department General surgery

Jinling Hospital, China

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