Cutaneous Hydration Assessment in SCD

Официальное название

Cutaneous Hydration Assessment in Sickle Cell Disease

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Dermal water content measurements in SCD participants at baseline state of health [Срок оценки: During a regularly scheduled clinic appointment, approximately 2 hours]
• Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE [Срок оценки: 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 [Срок оценки: During a VOC or VOE event after IV fluid resuscitation, approximately 2 hours]
• Clinical dehydration assessments in SCD participants [Срок оценки: At a regularly scheduled clinical appointment, approximately 2 hours]
• Measurement of serum osmolality as a laboratory biomarker of dehydration in SCD participants [Срок оценки: At a regularly scheduled clinical appointment, approximately 2 hours]
• Measurement of hyperadhesion as a laboratory biomarker of dehydration in SCD participants [Срок оценки: At a regularly scheduled clinical appointment, approximately 2 hours]
• Measurement of elongation index as a cellular biomarker of dehydration in SCD participants [Срок оценки: At a regularly scheduled clinical appointment, approximately 2 hours]
• Measurement of point of sickling as a biomarker of dehydration in SCD participants [Срок оценки: At a regularly scheduled clinical appointment, approximately 2 hours]
• Measurement of urine osmolality as a laboratory biomarker of dehydration in SCD participants [Срок оценки: 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 [Срок оценки: During a VOC or VOE event before resuscitation therapy, approximately 2 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Participants under 12-years old
• Participants being treated with experimental therapies in clinical trials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• UPMC Sickle Cell Clinic — Pittsburgh

Идентификаторы

NCT: NCT05210114 · STUDY21090014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗