Measurements of Resting Energy Expenditure in Patients With or at Risk of Developing Graft Versus Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility - can the procedure be adequately performed in a child?
研究概览
简要总结
This study aims to show that the MedGem indirect calorimetry measurement device will be feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD will have elevated REE that is not adequately predicted by standard equations.
详细描述
Chronic Graft versus Host Disease (GVHD) is an important cause of morbidity and mortality in patients undergoing allogeneic bone marrow and hematopoietic progenitor cell transplantation. In adults, it has been shown that patients with acute or chronic GVHD have an increase in their resting energy expenditure (REE), likely as a result of chronic systemic inflammation. These studies have not yet been performed in children. This study's objective is to determine the REE of pediatric patients with acute and chronic GVHD after hematopoietic stem cell transplantation (HSCT).
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
- 7 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 7-30 years of age
- •Signed informed consent
- •One of the following three criteria must be met:
- •Presence of grade II or greater acute GVHD as defined by Keystone criteria
- •Presence of clinically extensive chronic GVHD as defined by the revised Seattle criteria
- •Any subject identified prior to allogeneic transplant, or following allogeneic transplant, who is at risk for acute or chronic GVHD
排除标准
- •Inability to meet the requirements of the study procedures
- •Any subject who is receiving supplemental oxygen
- •Withdrawal of consent
结局指标
主要结局
Feasibility - can the procedure be adequately performed in a child?
时间窗: Spring of 2010
次要结局
- Measure of resting energy expenditure - kcal/day and oxygen consumption (VO2 mL/min)(Spring of 2012)