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临床试验/NCT03606603
NCT03606603已完成不适用

Nutrition Insights Day Asia to Assess Hospital Malnutrition and the Routine Use of Enteral and Parenteral Nutrition in Patients Following Major Gastrointestinal Surgery

Fresenius Kabi89 个研究点 分布在 4 个国家目标入组 590 人开始时间: 2019年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
590
试验地点
89
主要终点
Proportion of surgical patients with a caloric / protein deficit receiving EN and/or PN on the day before the NID in selected Asian countries.

研究概览

简要总结

This is an observational, cross-sectional study to be conducted on the Nutrition Insights Day (NID), with retrospective review of patient medical charts. No prospective follow-up period is considered.

This study aims to obtain a contemporary overview of the nutritional status, the use of EN and/or PN and the provision of calories and proteins in patients after major elective gastrointestinal surgery with existing malnutrition or at risk of hospital malnutrition in selected Asian countries.

研究设计

研究类型
Observational
观察模型
Other
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

  • Adult patients after elective major abdominal gastrointestinal surgery [i.e. elective major GI resections, partial or total, especially for cancer, including: esophagectomy, gastrectomy, enterectomy (small bowel resection), colectomy, hepatectomy, pancreatectomy, resections for gall bladder or bile duct cancer (cholangiocarcinoma)] with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications*, with indications for nutritional support
  • Hospitalization on SICU or major surgical ward on the NID
  • Use of EN (nutritional intake provided via tube feeding) and/or PN for at least one day before the NID
  • If patient received oral nutrition (ON) or oral nutrition supplements (ONS) during the observational phase from day -5 to day -2, complete and reliable data of daily caloric and protein intake is available
  • Latest surgical intervention ≤ 10 days before NID

排除标准

  • Patients with burn injuries
  • Patients requiring postsurgical mechanical ventilation and sedation on the NID
  • Patients receiving ON and/or ONS at any quantity on the day before the NID
  • Patients requiring emergency procedures

结局指标

主要结局

Proportion of surgical patients with a caloric / protein deficit receiving EN and/or PN on the day before the NID in selected Asian countries.

时间窗: On the day before the Nutrition Insights Day (day -1)

Caloric / protein deficit, i.e., difference between energy / protein target per day and actually administered energy/protein

次要结局

  • Absolute and relative caloric and protein balance(On the day before the Nutrition Insights Day (day -1))
  • Distribution within subcategories of caloric / protein balance(On the day before the Nutrition Insights Day (day -1))
  • Categorical, absolute and relative caloric balance based on standardized target intake (sensitivity analysis)(On the day before the Nutrition Insights Day (day -1))
  • Cumulative (absolute/ relative) caloric and protein balance(On the day before the Nutrition Insights Day (day -1))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (89)

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Nutrition Insights Day Asia | 临床试验