Recruiting

Fluid Monitoring

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07834710

Conditions

Fluid Overload

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

Interventions

Bioimpedance device

Study Details

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

Study ID

NCT07834710

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Ghafoor Ghafoor, MD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.