Fluid OverloadNCT07834710
Using Bioimpedance Analysis to Monitor Fluid Status in Children
An observational study of Fluid Overload, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Fluid Overload
- What is being tested?
- Bioimpedance device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Hematopoietic stem cell transplantation (HSCT) recipients who meet the Eligibility criteria and consent to participate
Who may be able to join
- Ages 6-21 years planned to undergo allogeneic or autologous HSCT for any indication with any preparative regimen.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
888-226-4343, referralinfo@stjude.org
About this study
Official title: Using Bioimpedance Analysis to Monitor Fluid Status in Children Undergoing Stem Cell Transplantation
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.
Read the detailed description
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).
- Conditions
- Fluid Overload
- Being tested
- Bioimpedance device
- Keywords
- Bioelectrical impedance analysis (BIA), Hematopoietic stem cell transplantation (HSCT) recipients, Allogeneic HSCT, Autologous HSCT
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance deviceDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Bioimpedance device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Ghafoor, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834710
- Sponsor's protocol ID
- BIAFLUID
- Other IDs
- NCI-2026-06802
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes