Using Bioimpedance Analysis to Monitor Fluid Status in Children
ConditionFluid Overload
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-21
SponsorSt. Jude Children's Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 6-21 years planned to undergo allogeneic or autologous HSCT for any indication with any preparative regimen.
Disqualifiers
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.
Trial population
Hematopoietic stem cell transplantation (HSCT) recipients who meet the Eligibility criteria and consent to participate
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bioimpedance device
Diagnostic testRoutine bioimpedance device measurements will be taken at specific times during the patient's initial hospitalization after the transplant. They will be performed alongside regular nursing assessments in the patient's hospital room.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Hematopoietic stem cell transplantation (HSCT) recipients1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of obtaining serial BIA-derived fluid markers during the initial HSCT hospitalization
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.
Time frame
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 year2
Longitudinal changes in total body water (TBW)
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.
Time frame
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 year3
Longitudinal changes in extracellular water (ECW)
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.
Time frame
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 year4
Longitudinal changes in intracellular water (ICW)
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.
Time frame
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 yearSecondary outcomes
1
Concordance between BIA-derived fluid markers and routine clinical fluid status assessments obtained at the same time points-Daily weight
Daily body weight (kg) will be compared with BIA-derived total body water (TBW), extracellular water (ECW), and intracellular water (ICW). The association between BIA-derived fluid markers and body weight will be assessed using correlation coefficients. Measurements will be summarized descriptively and visualized using scatterplots and aligned longitudinal plots.
Time frame
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 year2
Concordance between BIA-derived fluid markers and routine clinical fluid status assessments obtained at the same time points-Intake/Output
Net fluid balance (fluid intake minus fluid output), measured in milliliters (mL), will be compared with BIA-derived total body water (TBW), extracellular water (ECW), and intracellular water (ICW). The association between BIA-derived fluid markers and net fluid balance will be assessed using correlation coefficients. Measurements will be summarized descriptively and visualized using scatterplots and aligned longitudinal plots.
Time frame
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 yearSponsors and contacts
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Source ClinicalTrials.gov
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