An observational study in Fluid Overload, sponsored by St. Jude Children's Research Hospital. Recruiting at 1 site in United States. Open to participants aged 6 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by St. Jude Children's Research Hospital · Observational
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.
Primary Objective:
Secondary Objective:
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).
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's planned enrollment of 30 is below the median of 67 across 143 observational studies indexed under Edema.
Browse Edema studies →St. Jude Children's Research Hospital is the lead sponsor of 440 studies on the registry; 102 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hematopoietic stem cell transplantation (HSCT) recipients who meet the Eligibility criteria and consent to participate
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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 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.
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
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 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.
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
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 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.
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
Started Nov 2026 (actual). Primary completion is estimated for Jun 2027, 7 months after the start.
Of 76 non-industry observational studies under Edema, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 7 months is below that.
Counting every sponsor, half of 85 studies reached it within 23 months; a quarter within 7 and three quarters within 47.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 26, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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