Sickle Cell DiseaseNCT05210114
Cutaneous Hydration Assessment in SCD
A study testing Skin Hydration Sensor in people with Sickle Cell Disease, run by Enrico Novelli at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Skin Hydration Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants under 12-years old
- Participants being treated with experimental therapies in clinical trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Sickle Cell Clinic
Pittsburgh, Pennsylvania, 15213
Enrico Novelli, MD, 412-916-3416, noveex@upmc.edu
Manzoor Mohideen, PhD, 412-802-8498, mohideenm@upmc.edu
About this study
Official title: Cutaneous Hydration Assessment in Sickle Cell Disease
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).
Read the detailed 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Skin Hydration Sensor
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Hydration SensorDevice
Also called Delfin MoistureMeterEpiD
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.
| Study group | Role | What they receive |
|---|---|---|
| Skin Hydration Sensor | Experimental | Not described Receives: Device: Skin Hydration Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start21 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enrico Novelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enrico Novelli, University of Pittsburgh
- Investigators
- Enrico Novelli, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210114
- Sponsor's protocol ID
- STUDY21090014
- Status last verified
- Nov 2025
- First submitted
- 26 Dec 2021
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Hydration Assessment in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT05210114
- Acronym / sponsor ID
- STUDY21090014
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Enrico NovelliUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Hydration Sensor | Experimental | Device: Skin Hydration Sensor |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Participants under 12-years old
- Participants being treated with experimental therapies in clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Hydration SensorAlso: Delfin MoistureMeterEpiDThe 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. | Device | Skin Hydration Sensor |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrico Novelli, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Hydration Sensor in people with Sickle Cell Disease, run by Enrico Novelli at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico Novelli, MD (412-916-3416, noveex@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal water content measurements in SCD participants at baseline state of health (time frame: During a regularly scheduled clinic appointment, approximately 2 hours). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.