A Multi-center, Cross-sectional Observational Study on Nutritional Status and Body Composition of Adult Patients With Crohn's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Appendicular skeletal mass index
研究概览
简要总结
Patients with Crohn's disease generally have nutritional risks and malnutrition. The investigators will conduct a multicenter cross-sectional study to discover nutritional status and body composition of Chinese adult patients with CD.
详细描述
Several studies have found that the body composition of CD patients is related to disease and therapies. Due to lack of a prospective multicenter cross-sectional observational study on the nutritional status and body composition of adult patients with CD in China. Evaluating the nutritional status and body composition of these patients can help formulate individualized nutritional support strategies for adult CD patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Age ≥ 18 years old;
- •diagnosis of CD;
- •Admission time <48 hours;
- •Subject has voluntarily signed and dated an informed consent form.
排除标准
- •Emergency surgery for intestinal fistula or abdominal abscess;
- •Unstable vital signs or unstable hemodynamics;
- •Pregnant or lactating women;
- •Admission to hospital due to other critical illnesses (such as tumor, HIV, severe infections requiring ventilator or CRRT treatment);
- •Dying patients whose life expectancy does not exceed 24 hours;
- •Severe liver insufficiency (liver function score 11-15 or total bilirubin> 3mg/dL or tissue biopsy diagnosed as liver cirrhosis, hepatic encephalopathy, portal hypertension with history of gastrointestinal hemorrhage, etc.);
- •Severe renal insufficiency (creatinine value is 2 times higher than the upper limit of normal);
- •Severe metabolic diseases (such as metabolic syndrome, hyperthyroidism, etc.);
- •Patients whose burn area exceeds 20% of the body surface area;
- •Immunodeficiency, autoimmune disease, or receiving immunosuppressive treatment for diseases other than CD (such as organ transplantation, etc.);
- •Those who are not suitable for body composition analysis
- •Patients who have been selected for other clinical studies or have been selected for this study;
- •Subjects are unwilling to participate in this study or refuse to sign informed consent.
结局指标
主要结局
Appendicular skeletal mass index
时间窗: Within 48 hours of admission to hospital
Bioelectrical impedance analysis
次要结局
- Body composition(Within 48 hours of admission to hospital)
- Nutritional risk screening(Within 48 hours of admission to hospital)
- Nutritional assessment(Within 48 hours of admission to hospital)
- Grip strength(Within 48 hours of admission to hospital)