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Cutaneous Hydration Assessment in SCD

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ClinicalTrials.gov Identifier: NCT05210114
Recruitment Status : Recruiting
First Posted : January 27, 2022
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
Enrico M Novelli, University of Pittsburgh

Study Description
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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
Sickle Cell Disease Device: Skin Hydration Sensor Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 21, 2022
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Delfin MoistureMeterEpiD


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05210114


Contacts
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Contact: Enrico Novelli, MD 412-916-3416 noveex@upmc.edu
Contact: Manzoor Mohideen, PhD 412-648-6920 mohideenm@upmc.edu

Locations
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United States, Pennsylvania
UPMC Sickle Cell Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Enrico Novelli, MD    412-916-3416    noveex@upmc.edu   
Contact: Manzoor Mohideen, PhD    4126486920    mohideenm@upmc.edu   
Principal Investigator: Enrico Novelli, MD         
Sponsors and Collaborators
Enrico M Novelli
Investigators
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Principal Investigator: Enrico Novelli, MD University of Pittsburgh
More Information
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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: January 27, 2022    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn