Cutaneous Hydration Assessment in SCD
1 other identifier
interventional
30
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2021
CompletedStudy Start
First participant enrolled
January 21, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
November 12, 2025
November 1, 2025
4.9 years
December 26, 2021
November 10, 2025
Conditions
Outcome Measures
Primary Outcomes (19)
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
Study Arms (1)
Skin Hydration Sensor
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participants under 12-years old
- Participants being treated with experimental therapies in clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Enrico Novellilead
Study Sites (1)
UPMC Sickle Cell Clinic
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enrico Novelli, MD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor and Section Chief - Classical Hematology
Study Record Dates
First Submitted
December 26, 2021
First Posted
January 27, 2022
Study Start
January 21, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
November 12, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share