NCT05210114 · Enrico Novelli
Cutaneous Hydration Assessment in SCD
What this study is about
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).
View original scientific description
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).
Interventions
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.
Primary outcome measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Pittsburgh, Pennsylvania
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 12, 2025 · Source of record for eligibility and locations