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临床试验/NCT04535570
NCT04535570已完成不适用

Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation in Patients With Hematological Disease and Associated Factors

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Energy expenditure

研究概览

简要总结

The treatment before bone marrow transplantantion is initiated by chemotherapy associated or not with radiotherapy, both of which cause various side effects on the patient as symptoms that impair food intake. The nutritional status of the patient is one of the factors related to the success of the transplant, so a complete nutritional assessment before transplantation is necessary in order to identify patients at nutritional risk, nutritional disorders and to perform appropriate and early intervention to promote recovery and / or health maintenance. Will be used for nutritional assessment: arm perimeter, arm muscle area; electrical bioimpedance, phase angle, and Indirect Calorimetry, a standard method of noninvasive nutritional assessment that expresses the nutritional demand and rate of utilization of energy substrates from oxygen consumption and carbon dioxide production through the air inhaled and exhaled by the individual's lungs.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Patients with hematological disease
  • Age equal or superior to 15 years old
  • Both sexes
  • Will be submitted bone marrow transplantation

排除标准

  • Age below 15 years old
  • Those who can't perform calorimetry (oxygen therapy, mechanical ventilation)
  • Have hyper or hypothyroidism
  • Admitted to the Intensive Care Unit (without at least one result of post-transplant indirect calorimetry)
  • Don't agree to participate in the study

结局指标

主要结局

Energy expenditure

时间窗: Up to 3 weeks after protocol termination

The energy expenditure will be analyzed by the volume of oxygen (VO2) consumed, the volume of carbon dioxide (VCO2) produced and the respiratory quotient (VO2 / VCO2). The values analyzed will be the results of the measures of energy expenditure (BMR) before and after the transplant, in calories (Kcal), to verify changes caused by chemotherapy and / or radiation therapy.

次要结局

  • Nutritional status of patients(Up to 3 weeks after protocol termination)
  • Caloric and protein adequacy(Up to 3 weeks after protocol termination)
  • Clinical outcomes(Up to 3 weeks after protocol termination)

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

Principal investigator

Federal University of Minas Gerais

研究点 (1)

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