Cutaneous Hydration Assessment in SCD

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Cutaneous Hydration Assessment in Sickle Cell Disease

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Device: Skin Hydration Sensor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin Hydration Sensor<br> | Device: Skin Hydration Sensor<br>* 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.<br>* Other names: Delfin MoistureMeterEpiD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours |