Using Bioimpedance Analysis to Monitor Fluid Status in Children Undergoing Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of obtaining serial BIA-derived fluid markers during the initial HSCT hospitalization
研究概览
简要总结
This study aims to develop a more comprehensive approach to monitoring fluid status in patients undergoing stem cell transplantation by combining conventional methods with a bioimpedance device.
详细描述
Primary Objective:
- To evaluate the feasibility of obtaining serial bedside bioimpedance analysis (BIA) measurements during the initial hematopoietic stem cell transplantation hospitalization, defined by the proportion of scheduled assessments successfully completed at prespecified time points, and to descriptively characterize within-patient longitudinal changes in total body water (TBW), extracellular water (ECW), and intracellular water (ICW).
Secondary Objective:
- To compare BIA-derived fluid measurements with routine clinical fluid assessment methods (e.g., daily weights and intake/output records) obtained at the same time points, to assess concordance and to evaluate whether BIA may support a more standardized approach to fluid monitoring in pediatric HSCT patients.
Routine bioimpedance device measurements will be taken at specific times during the patient's initial hospitalization after the hematopoietic stem cell transplantation. These times include pre-transplantation, every other day for the first two weeks post-transplant, and then once a week during their initial hospitalization up to one year. They will be performed alongside regular nursing assessments in the patient's hospital room.
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
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 6-21 years planned to undergo allogeneic or autologous HSCT for any indication with any preparative regimen.
排除标准
- •Pacemaker implantation due to incompatibility with the bioimpedance device
- •Lack of agreement from the primary HSCT physician.
- •Inability or unwillingness of the research participant and/or legal guardian/representative to provide written informed consent.
研究组 & 干预措施
Hematopoietic stem cell transplantation (HSCT) recipients
Participants ages 6-21 years planned to undergo allogeneic or autologous HSCT for any indication with any preparative regimen who meet the eligibility criteria and consent will be enrolled. Routine bioimpedance device measurements will be taken at specific times during the participant's initial hospitalization after the transplant.
干预措施: Bioimpedance device (Diagnostic Test)
结局指标
主要结局
Feasibility of obtaining serial BIA-derived fluid markers during the initial HSCT hospitalization
时间窗: Baseline (before transplantation), Day 0 (on day of transplant), Day 1-14 (every other day for initial two weeks post-transplant), Once a week during the initial hospitalization post-transplantation up to one year
Feasibility will be assessed descriptively as the proportion of scheduled BIA assessments successfully completed at prespecified time points. No formal feasibility threshold is prespecified. Instead, completion rates will be interpreted in context, considering operational factors such as patient acuity, ICU transfer, and early discharge. As a general reference, higher completion rates (e.g., ≥70-80%) would be considered supportive of feasibility.
Longitudinal changes in total body water (TBW)
时间窗: Baseline (before transplantation), Day 0 (on day of transplant), Day 1-14 (every other day for initial two weeks post-transplant), Once a week during the initial hospitalization post-transplantation up to one year
Bioelectrical impedance analysis (BIA) will be used to estimate total body water (TBW) in liters (L). The primary metric for this outcome will be the absolute TBW value at each assessment time point and the longitudinal change in TBW from baseline. Changes in TBW over time will be summarized descriptively.
Longitudinal changes in extracellular water (ECW)
时间窗: Baseline (before transplantation), Day 0 (on day of transplant), Day 1-14 (every other day for initial two weeks post-transplant), Once a week during the initial hospitalization post-transplantation up to one year
Bioelectrical impedance analysis (BIA) will be used to estimate extracellular water (ECW) in liters (L). The primary metric for this outcome will be the absolute ECW value at each assessment time point and the longitudinal change in ECW from baseline. The ECW-to-total body water ratio (ECW/TBW) will also be calculated as a measure of the relative distribution of body water between the extracellular and total body water compartments. Changes in ECW and ECW/TBW over time will be summarized descriptively.
Longitudinal changes in intracellular water (ICW)
时间窗: Baseline (before transplantation), Day 0 (on day of transplant), Day 1-14 (every other day for initial two weeks post-transplant), Once a week during the initial hospitalization post-transplantation up to one year
Bioelectrical impedance analysis (BIA) will be used to estimate intracellular water (ICW) in liters (L). The primary metric for this outcome will be the absolute ICW value at each assessment time point and the longitudinal change in ICW from baseline. Changes in ICW over time will be summarized descriptively.
次要结局
- Concordance between BIA-derived fluid markers and routine clinical fluid status assessments obtained at the same time points-Daily weight(Baseline (before transplantation), Day 0 (on day of transplant), Day 1-14 (every other day for initial two weeks post-transplant), Once a week during the initial hospitalization post-transplantation up to one year)
- Concordance between BIA-derived fluid markers and routine clinical fluid status assessments obtained at the same time points-Intake/Output(Baseline (before transplantation), Day 0 (on day of transplant), Day 1-14 (every other day for initial two weeks post-transplant), Once a week during the initial hospitalization post-transplantation up to one year)