An interventional study of Skin Hydration Sensor in Sickle Cell Disease, sponsored by Enrico Novelli. Recruiting at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-11-12.
Sponsored by Enrico Novelli · Not applicable, Interventional, and Diagnostic
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).
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.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Enrico Novelli is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Device: Skin Hydration Sensor
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.
Also known as: Delfin MoistureMeterEpiD
Dermal water content measurements in SCD participants at baseline state of health
Delfin MoistureMeterEpiD hydration sensor will be used to measure dermal water content in 20 participants at 1 time point.
Time frame: During a regularly scheduled clinic appointment, approximately 2 hours
Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE
Delfin MoistureMeterEpiD hydration sensor will be used to measure dermal water content in 10 participants.
Time frame: During a VOC or VOE event before IV fluid resuscitation, approximately 2 hours
Dermal water content measurements after fluid resuscitation in SCD participants with VOC or VOE
Delfin MoistureMeterEpiD hydration sensor will be used to measure dermal water content in 10 participants.
Time frame: During a VOC or VOE event after IV fluid resuscitation, approximately 2 hours
Clinical dehydration assessments in SCD participants
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.
Time frame: At a regularly scheduled clinical appointment, approximately 2 hours
Measurement of serum osmolality as a laboratory biomarker of dehydration in SCD participants
Serum osmolality values of \>290 milliosmol/kg is considered abnormal. It will be measured at 1 timepoint in 20 participants.
Time frame: At a regularly scheduled clinical appointment, approximately 2 hours
Measurement of hyperadhesion as a laboratory biomarker of dehydration in SCD participants
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.
Time frame: At a regularly scheduled clinical appointment, approximately 2 hours
Measurement of elongation index as a cellular biomarker of dehydration in SCD participants
Cellular dehydration marker, the elongation index, will be measured by ektacytometry. It will be measured at 1 timepoint in 20 participants.
Time frame: At a regularly scheduled clinical appointment, approximately 2 hours
Measurement of point of sickling as a biomarker of dehydration in SCD participants
Point of sickling, a cellular dehydration biomarker, will be measured by ektacytometry. It will be measured at 1 timepoint in 20 participants.
Time frame: At a regularly scheduled clinical appointment, approximately 2 hours
Measurement of urine osmolality as a laboratory biomarker of dehydration in SCD participants
Urine osmolality values \<450 milliosmol/kg is considered abnormal in adults without fluid restrictions. It will be measured at 1 timepoint in 20 participants.
Time frame: At a regularly scheduled clinical appointment, approximately 2 hours
Measurement of serum osmolality as a laboratory biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE
Serum osmolality values of \>290 milliosmol/kg is considered abnormal. It will be measured at 1 timepoint in 10 participants.
Time frame: During a VOC or VOE event before resuscitation therapy, approximately 2 hours
Measurement of serum osmolality as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
Serum osmolality values of \>290 milliosmol/kg is considered abnormal. It will be measured at 1 timepoint in 10 participants.
Time frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Measurement of hyperadhesion as a laboratory biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE
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.
Time frame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours
Measurement of hyperadhesion as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
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.
Time frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Measurement of elongation index as a cellular biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE
Cellular dehydration marker, the elongation index, will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.
Time frame: During a VOC or VOE event before fluid resuscitation, approximately 2 hours
Measurement of elongation index as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
Cellular dehydration marker, the elongation index will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.
Time frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Measurement of point of sickling as a cellular biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE
Cellular dehydration marker, the elongation index will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.
Time frame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours
Measurement of point of sickling as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
Cellular dehydration marker, the elongation index will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.
Time frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Measurement of urine osmolality as laboratory biomarkers of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE
Urine osmolality values \<450 milliosmol/kg is considered abnormal in adults without fluid restrictions. It will be measured at 1 timepoint in 10 participants.
Time frame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours
Measurement of urine osmolality as laboratory biomarkers of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
Urine osmolality values \<450 milliosmol/kg is considered abnormal in adults without fluid restrictions. It will be measured at 1 timepoint in 10 participants.
Time frame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Plan to share: No
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Enrico Novelli