Using Bioimpedance Analysis to Monitor Fluid Status in Children

NCT07834710 | Not Yet Recruiting FDA Device

• 2 other identifiers: BIAFLUIDNCI-2026-06802
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fluid Overload

Keywords

Bioelectrical impedance analysis (BIA); Hematopoietic stem cell transplantation (HSCT) recipients; Allogeneic HSCT; Autologous HSCT

Outcome Measures

Primary Outcomes (4)

• 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.

  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

• 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.

  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

• 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.

  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

• 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.

  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

Secondary Outcomes (2)

• 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

Study Arms (1)

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.

Diagnostic Test: Bioimpedance device

Interventions

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.

Hematopoietic stem cell transplantation (HSCT) recipients

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hematopoietic stem cell transplantation (HSCT) recipients who meet the Eligibility criteria and consent to participate

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Saad Ghafoor, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghafoor Ghafoor, MD

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

US (1)