Assessing skin hydration in patients with sickle cell disease
Cutaneous Hydration Assessment in Sickle Cell Disease
This study is testing a new skin sensor to see if it can help people with sickle cell disease manage their hydration better, especially during painful episodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05210114 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the accuracy of a cutaneous hydration sensor for assessing hydration status in patients with sickle cell disease (SCD). The sensor will be evaluated for its feasibility as a point-of-care device to guide hydration therapy, particularly during vaso-occlusive episodes (VOE). Participants will have their skin hydration measured at baseline and after fluid resuscitation therapy, with blood and urine samples collected for comparison with laboratory biomarkers. The goal is to improve hydration management and prevent complications associated with improper fluid administration.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12 and older diagnosed with sickle cell disease.
Not a fit: Patients under 12 years old or those receiving experimental therapies in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better hydration management in patients with sickle cell disease, potentially reducing hospitalizations and improving patient outcomes.
How similar studies have performed: While the use of hydration sensors is emerging, this specific approach to hydration assessment in sickle cell disease is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Sickle Cell Disease (genotypes SS, SC, Sß-thalassemia, SD, SOArab) * Participants must be ≥12-years old * Participants that provide legally effective consent to all study procedures Exclusion Criteria: * Participants under 12-years old * Participants being treated with experimental therapies in clinical trials
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Sickle Cell Clinic — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Enrico Novelli, MD — University of Pittsburgh
- Study coordinator: Enrico Novelli, MD
- Email: noveex@upmc.edu
- Phone: 412-916-3416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.