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临床试验/NCT03357848
NCT03357848Unknown不适用

Impact of Caloric and Protein Adequacy on Postoperative Clinical Outcomes of Patients Undergoing Major Abdominal Surgery

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年12月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Postoperative complications

研究概览

简要总结

The role of nutritional therapy (TN) in the surgical patient is well described in the literature and is associated with reductions in postoperative complications, length of hospital stay, and mortality. Adequate determination of caloric and protein requirements is an essential step in the TN institution, avoiding hypoalimentation and hyperalimentation. Thus, it is essential to understand the changes in energy expenditure after surgery and its relation with nutritional status. In addition, little is known about the effect of nutritional therapy and caloric adequacy on parameters such as phase angle and dynamometry. Thus, the objective of this study is to evaluate the changes in energy expenditure after major abdominal surgeries and to evaluate the phase angle and dynamometry as possible markers of nutritional therapy. Energy expenditure will be assessed by indirect calorimetry. Functionality will be assessed by means of dynamometry and 6-minute walk test. Nutritional diagnosis will be given through subjective global assessment. Energy and protein intake will be monitored and registered daily. Phase angle will be obtained by performing bioelectrical impedance.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years old
  • Patients admitted for major abdominal surgery
  • Sign the consent form

排除标准

  • Length of hospital stay less than 3 days
  • Pregnancy
  • Patients who, for any reason, can not perform indirect calorimetry

结局指标

主要结局

Postoperative complications

时间窗: 30 days after surgery

According to the Dindo-Clavien protocol

次要结局

  • Phase angle(24 hours pre-surgery, 3 and 7 days after surgery)
  • Body composition(24 hours pre-surgery, 3 and 7 days after surgery)
  • Nutritional status(24 hours pre-surgery and 7 days after surgery)
  • Functional status(24 hours pre-surgery, 3 and 7 days after surgery)
  • Energy expenditure(3, 5 and 7 days after surgery)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Isabel Toulson Davisson Correia

Professor/ Nutrition Service Coordinator

Federal University of Minas Gerais

研究点 (1)

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