Cutaneous Hydration Assessment in SCD

Sponsor
Enrico M Novelli (Other)
Overall Status
Recruiting
CT.gov ID
NCT05210114
Collaborator
(none)
30
1
1
33.3
0.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Skin Hydration Sensor
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Cutaneous Hydration Assessment in Sickle Cell Disease
Actual Study Start Date :
Jan 21, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Skin Hydration Sensor

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.
Other Names:
  • Delfin MoistureMeterEpiD
  • Outcome Measures

    Primary Outcome Measures

    1. Dermal water content measurements in SCD participants at baseline state of health [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.

    2. Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE [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.

    3. Dermal water content measurements after fluid resuscitation in SCD participants with VOC or VOE [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.

    4. Clinical dehydration assessments in SCD participants [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.

    5. Measurement of serum osmolality as a laboratory biomarker of dehydration in SCD participants [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.

    6. Measurement of hyperadhesion as a laboratory biomarker of dehydration in SCD participants [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.

    7. Measurement of elongation index as a cellular biomarker of dehydration in SCD participants [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.

    8. Measurement of point of sickling as a biomarker of dehydration in SCD participants [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.

    9. Measurement of urine osmolality as a laboratory biomarker of dehydration in SCD participants [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.

    10. Measurement of serum osmolality as a laboratory biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE [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.

    11. Measurement of serum osmolality as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE [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.

    12. Measurement of hyperadhesion as a laboratory biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE [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.

    13. Measurement of hyperadhesion as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE [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.

    14. Measurement of elongation index as a cellular biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE [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.

    15. Measurement of elongation index as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE [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.

    16. Measurement of point of sickling as a cellular biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE [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.

    17. Measurement of point of sickling as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE [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.

    18. Measurement of urine osmolality as laboratory biomarkers of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE [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.

    19. Measurement of urine osmolality as laboratory biomarkers of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UPMC Sickle Cell Clinic Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • Enrico M Novelli

    Investigators

    • Principal Investigator: Enrico Novelli, MD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Enrico M Novelli, Associate Professor and Section Chief - Benign Hematology, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT05210114
    Other Study ID Numbers:
    • STUDY21090014
    First Posted:
    Jan 27, 2022
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022