NCT02831725Unknown不适用
An Observational Cohort Study to Establish Accurate Nutrition Therapy for Critically Ill Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- complications after the operation
研究概览
简要总结
- Demographics data;
- Nutritional evaluation data;
- All biochemical monitoring data during the study period;
- All nutritional treatment data will be recorded daily during the study period, including actual calorie intake, protein intake, and the proportion of calorie/protein administered by EN and/or PN route. The nutritional treatment protocol will be decided by the attending physician, the investigator will not intervene.
- A blood sample (5 ml) will be drawn from every patient immediately after they enroll into the study, and the metabolomics of the samples will be analyzed analysis using a combined 800 MHz 1H-NMR-UPLC-MS system. The data will then be used to establish metabolic profile baseline.
- We will establish a sub-group that contains 20 patients (chosen from enrolled patients according to APACHE II scores: 10 patients are APACHE II scores in 21-30). We will take one blood sample daily during the whole study period. The plasma sample will be used for metabolomics analysis using an 800 MHz 1H-NMR-UPLC-MS system. And the data will be used for metabolic dynamic modeling.
- Clinical outcomes data, which include: 1) Complications after the operation (intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection); 2) death event; 3) ICU-stay; 4) Length of 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18-70
- •patients are underwent Whipple operation or subtotal gastrectomy and ever admitted to intensive care unit (ICU) after the operation
- •receive parenteral or enteral nutrition > 3 days
排除标准
- •has metabolic disorders: diabetes, thyroid disease
- •Pregnant or breastfeeding
- •The presence of drug or alcohol dependence
- •The presence of tuberculosis, HIV infection and other acute infectious disease
- •Serious liver, kidney, heart and other vital organ failure
结局指标
主要结局
complications after the operation
时间窗: three years
intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Nutrition in People With a Lower Limb AmputationDiet, Food, and NutritionNutrition DisordersAmputationNCT05747066University Medical Center Groningen81
已完成
不适用
Immunophenotyping Assessment in a COVID-19 CohortCoronavirus Disease 2019 (COVID-19)SARS-CoV-2NCT04378777National Institute of Allergy and Infectious Diseases (NIAID)1,227
已完成
不适用
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory SupportNon-invasive Ventilatory SupportInfant Respiratory Distress SyndromeNCT01861795Takeda40
Enrolling By Invitation
不适用
Epidemiological Observatory on the Health Conditions of Inpatients Aged 65 or Older at the INRCA Research HospitalsAgingInpatientsNCT01397682Istituto Nazionale di Ricovero e Cura per Anziani2,250
Unknown
不适用
Cohort Study to Evaluate Ovarian FunctionFemale Infertility Due to Diminished Ovarian ReserveMenopausal SyndromeSexual Function and Fertility DisordersCardiovascular DiseasesNCT02294500Shixuan Wang6,000