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NCT Number: NCT07834710

Using Bioimpedance Analysis to Monitor Fluid Status in Children

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.

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Key information

Conditions

Fluid Overload Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Along with bioimpedance data, laboratory tests and radiographic data will be collected only if obtained as part of the typical standard of care. The following clinical data will be collected: weights and inputs-and-outputs (standard of care items).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 6-21 years planned to undergo allogeneic or autologous HSCT for any indication with any preparative regimen.

Exclusion criteria

  • 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.

Treatment and study plan

Bioimpedance device

Diagnostic Test

Routine 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.

Primary outcomes

  1. Feasibility of obtaining serial BIA-derived fluid markers during the initial HSCT hospitalization

    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 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.

  2. Longitudinal changes in total body water (TBW)

    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 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.

  3. Longitudinal changes in extracellular water (ECW)

    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 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.

  4. Longitudinal changes in intracellular water (ICW)

    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 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.

Secondary outcomes

  1. Concordance between BIA-derived fluid markers and routine clinical fluid status assessments obtained at the same time points-Daily weight

    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 year

    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.

  2. Concordance between BIA-derived fluid markers and routine clinical fluid status assessments obtained at the same time points-Intake/Output

    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 year

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Official study title

Using Bioimpedance Analysis to Monitor Fluid Status in Children Undergoing Stem Cell Transplantation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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