Clinical trial NCT05210114: Cutaneous Hydration Assessment in SCD
Official title: Cutaneous Hydration Assessment in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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.

Eligibility 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

Primary outcomes:
measure: Dermal water content measurements in SCD participants at baseline state of health
timeFrame: During a regularly scheduled clinic appointment, approximately 2 hours
measure: Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event before IV fluid resuscitation, approximately 2 hours
measure: Dermal water content measurements after fluid resuscitation in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event after IV fluid resuscitation, approximately 2 hours
measure: Clinical dehydration assessments in SCD participants
timeFrame: At a regularly scheduled clinical appointment, approximately 2 hours
measure: Measurement of serum osmolality as a laboratory biomarker of dehydration in SCD participants
timeFrame: At a regularly scheduled clinical appointment, approximately 2 hours
measure: Measurement of hyperadhesion as a laboratory biomarker of dehydration in SCD participants
timeFrame: At a regularly scheduled clinical appointment, approximately 2 hours
measure: Measurement of elongation index as a cellular biomarker of dehydration in SCD participants
timeFrame: At a regularly scheduled clinical appointment, approximately 2 hours
measure: Measurement of point of sickling as a biomarker of dehydration in SCD participants
timeFrame: At a regularly scheduled clinical appointment, approximately 2 hours
measure: Measurement of urine osmolality as a laboratory biomarker of dehydration in SCD participants
timeFrame: At a regularly scheduled clinical appointment, approximately 2 hours
measure: Measurement of serum osmolality as a laboratory biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event before resuscitation therapy, approximately 2 hours
measure: Measurement of serum osmolality as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
measure: Measurement of hyperadhesion as a laboratory biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours
measure: Measurement of hyperadhesion as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
measure: Measurement of elongation index as a cellular biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event before fluid resuscitation, approximately 2 hours
measure: Measurement of elongation index as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
measure: Measurement of point of sickling as a cellular biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours
measure: Measurement of point of sickling as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
measure: Measurement of urine osmolality as laboratory biomarkers of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours
measure: Measurement of urine osmolality as laboratory biomarkers of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
timeFrame: During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Sickle Cell Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Enrico Novelli, MD
role: PRINCIPAL_INVESTIGATOR
References: