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Cutaneous Hydration Assessment in SCD

NCT ID: NCT05210114

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-21

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Sickle Cell Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Skin Hydration Sensor

Group Type EXPERIMENTAL

Skin Hydration Sensor

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Delfin MoistureMeterEpiD

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Enrico Novelli

OTHER

Sponsor Role lead

Responsible Party

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Enrico Novelli

Associate Professor and Section Chief - Classical Hematology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Enrico Novelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Sickle Cell Clinic

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Enrico Novelli, MD

Role: CONTACT

Phone: 412-916-3416

Email: [email protected]

Manzoor Mohideen, PhD

Role: CONTACT

Phone: 412-802-8498

Email: [email protected]

Facility Contacts

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Enrico Novelli, MD

Role: primary

Manzoor Mohideen, PhD

Role: backup

Other Identifiers

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STUDY21090014

Identifier Type: -

Identifier Source: org_study_id