Cutaneous Hydration Assessment in SCD
- Conditions
- Sickle Cell Disease
- Interventions
- Device: Skin Hydration Sensor
- Registration Number
- NCT05210114
- Lead Sponsor
- Enrico Novelli
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- Participants under 12-years old
- Participants being treated with experimental therapies in clinical trials
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Skin Hydration Sensor Skin Hydration Sensor -
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UPMC Sickle Cell Clinic
🇺🇸Pittsburgh, Pennsylvania, United States