Cutaneous Hydration Assessment in SCD

  • STATUS
    Recruiting
  • End date
    Oct 31, 2024
  • participants needed
    30
  • sponsor
    Enrico M Novelli
Updated on 26 April 2022
thalassemia

Summary

This study will validate the diagnostic accuracy of a cutaneous hydration sensor. This sensor will also be evaluated for its feasibility as a point-of-care device for the assessment of hydration status and its potential to guide hydration therapy in patients with sickle cell disease (SCD).

Description

Vaso-occlusive episodes (VOE) are the leading cause of hospitalization for patients with SCD. Intravenous fluid replacement is one of the cornerstones of management of VOE in the emergency department and throughout hospitalization. However, there are no evidence-based guidelines specifying the optimal administration of maintenance fluids. Overly aggressive hydration therapy imparts the risk of hypervolemia and pulmonary edema, which may lead to acute chest syndrome and death. Thus, a reliable biomarker is needed to gauge hydration status and guide fluid replacement strategies with the goal of achieving euvolemia.

The investigators propose a point-of-care test that may inform management (e.g., bolus vs. continuous infusion of maintenance intravenous fluid), and prevent over- or under-hydration. For this purpose, investigators seek to validate the diagnostic accuracy of a cutaneous hydration sensor, Delfin MoistureMeterEpiD (a non-significant risk device) and evaluate its feasibility as a point-of-care device for the assessment of hydration status and potentially guide hydration therapy in patients with SCD. Investigators will measure skin hydration in the clinic when participants are at baseline state of health. Skin hydration before and after fluid resuscitation therapy in patients with vaso-occlusive crisis (VOC) or VOE will also be assessed. Blood and urine will be collected to compare assessments of skin hydration with laboratory biomarkers of hypertonicity and red blood cell dehydration.

Details
Condition Sickle Cell Disease
Treatment Skin Hydration Sensor
Clinical Study IdentifierNCT05210114
SponsorEnrico M Novelli
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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
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