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NCT Number: NCT05210114

Cutaneous Hydration Assessment in SCD

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).

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin Hydration Sensor

Device

The device is a skin hydration sensor. The sensor is placed on the skin at the inner arm. It is non-invasive and measures in seconds the percent water content of the dermis by quantifying its dielectric constant.

Other names: Delfin MoistureMeterEpiD

Primary outcomes

  1. Dermal water content measurements in SCD participants at baseline state of health

    Time frame: During a regularly scheduled clinic appointment, approximately 2 hours

    Delfin MoistureMeterEpiD hydration sensor will be used to measure dermal water content in 20 participants at 1 time point.

  2. Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event before IV fluid resuscitation, approximately 2 hours

    Delfin MoistureMeterEpiD hydration sensor will be used to measure dermal water content in 10 participants.

  3. Dermal water content measurements after fluid resuscitation in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event after IV fluid resuscitation, approximately 2 hours

    Delfin MoistureMeterEpiD hydration sensor will be used to measure dermal water content in 10 participants.

  4. Clinical dehydration assessments in SCD participants

    Time frame: At a regularly scheduled clinical appointment, approximately 2 hours

    Clinical assessment of dehydration will be ascertained by administering the 10-point Clinical Dehydration Scale (CDS). CDS uses clinical characteristics (general appearance, eyes, mucous membranes, and tears), each of which are scored 0, 1, or 2 for a total score of 0 to 8, with 0 representing no dehydration; 1 to 4, some dehydration; and 5 to 8, moderate/severe dehydration. It will be administered at 1 time point in 20 participants.

  5. Measurement of serum osmolality as a laboratory biomarker of dehydration in SCD participants

    Time frame: At a regularly scheduled clinical appointment, approximately 2 hours

    Serum osmolality values of >290 milliosmol/kg is considered abnormal. It will be measured at 1 timepoint in 20 participants.

  6. Measurement of hyperadhesion as a laboratory biomarker of dehydration in SCD participants

    Time frame: At a regularly scheduled clinical appointment, approximately 2 hours

    As a marker of hyperadhesion capillary transit time will be measured using capillary mimicking microfluidic channels. It will be measured at 1 timepoint in 20 participants.

  7. Measurement of elongation index as a cellular biomarker of dehydration in SCD participants

    Time frame: At a regularly scheduled clinical appointment, approximately 2 hours

    Cellular dehydration marker, the elongation index, will be measured by ektacytometry. It will be measured at 1 timepoint in 20 participants.

  8. Measurement of point of sickling as a biomarker of dehydration in SCD participants

    Time frame: At a regularly scheduled clinical appointment, approximately 2 hours

    Point of sickling, a cellular dehydration biomarker, will be measured by ektacytometry. It will be measured at 1 timepoint in 20 participants.

  9. Measurement of urine osmolality as a laboratory biomarker of dehydration in SCD participants

    Time frame: At a regularly scheduled clinical appointment, approximately 2 hours

    Urine osmolality values <450 milliosmol/kg is considered abnormal in adults without fluid restrictions. It will be measured at 1 timepoint in 20 participants.

  10. Measurement of serum osmolality as a laboratory biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event before resuscitation therapy, approximately 2 hours

    Serum osmolality values of >290 milliosmol/kg is considered abnormal. It will be measured at 1 timepoint in 10 participants.

  11. Measurement of serum osmolality as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours

    Serum osmolality values of >290 milliosmol/kg is considered abnormal. It will be measured at 1 timepoint in 10 participants.

  12. Measurement of hyperadhesion as a laboratory biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours

    As a marker of hyperadhesion, capillary transit time will be measured using capillary mimicking microfluidic channels. It will be measured at 1 timepoint in 10 participants.

  13. Measurement of hyperadhesion as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours

    As a marker of hyperadhesion, capillary transit time will be measured using capillary mimicking microfluidic channels. It will be measured at 1 timepoint in 10 participants.

  14. Measurement of elongation index as a cellular biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event before fluid resuscitation, approximately 2 hours

    Cellular dehydration marker, the elongation index, will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.

  15. Measurement of elongation index as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours

    Cellular dehydration marker, the elongation index will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.

  16. Measurement of point of sickling as a cellular biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours

    Cellular dehydration marker, the elongation index will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.

  17. Measurement of point of sickling as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours

    Cellular dehydration marker, the elongation index will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.

  18. Measurement of urine osmolality as laboratory biomarkers of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours

    Urine osmolality values <450 milliosmol/kg is considered abnormal in adults without fluid restrictions. It will be measured at 1 timepoint in 10 participants.

  19. Measurement of urine osmolality as laboratory biomarkers of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE

    Time frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours

    Urine osmolality values <450 milliosmol/kg is considered abnormal in adults without fluid restrictions. It will be measured at 1 timepoint in 10 participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Novelli, MD

CONTACT

[email protected]

412-916-3416

Manzoor Mohideen, PhD

CONTACT

[email protected]

412-802-8498

Sponsors and collaborators

Lead sponsor

Enrico Novelli

Other

Registry information

Official study title

Cutaneous Hydration Assessment in Sickle Cell Disease

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 27, 2022
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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