Cutaneous Hydration Assessment in SCD

Sickle Cell Disease Clinical Trial

Official title:

Cutaneous Hydration Assessment in Sickle Cell Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05210114
• Other study ID #: STUDY21090014
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: Enrico Novelli, MD
• Phone: 412-916-3416
• Email: noveex[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Sickle Cell Clinic	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Enrico M Novelli

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermal water content measurements in SCD participants at baseline state of health	Delfin MoistureMeterEpiD hydration sensor will be used to measure dermal water content in 20 participants at 1 time point.	During a regularly scheduled clinic appointment, approximately 2 hours
Primary	Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE	Delfin MoistureMeterEpiD hydration sensor will be used to measure dermal water content in 10 participants.	During a VOC or VOE event before IV fluid resuscitation, approximately 2 hours
Primary	Dermal water content measurements after fluid resuscitation in SCD participants with VOC or VOE	Delfin MoistureMeterEpiD hydration sensor will be used to measure dermal water content in 10 participants.	During a VOC or VOE event after IV fluid resuscitation, approximately 2 hours
Primary	Clinical dehydration assessments in SCD participants	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.	At a regularly scheduled clinical appointment, approximately 2 hours
Primary	Measurement of serum osmolality as a laboratory biomarker of dehydration in SCD participants	Serum osmolality values of >290 milliosmol/kg is considered abnormal. It will be measured at 1 timepoint in 20 participants.	At a regularly scheduled clinical appointment, approximately 2 hours
Primary	Measurement of hyperadhesion as a laboratory biomarker of dehydration in SCD participants	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.	At a regularly scheduled clinical appointment, approximately 2 hours
Primary	Measurement of elongation index as a cellular biomarker of dehydration in SCD participants	Cellular dehydration marker, the elongation index, will be measured by ektacytometry. It will be measured at 1 timepoint in 20 participants.	At a regularly scheduled clinical appointment, approximately 2 hours
Primary	Measurement of point of sickling as a biomarker of dehydration in SCD participants	Point of sickling, a cellular dehydration biomarker, will be measured by ektacytometry. It will be measured at 1 timepoint in 20 participants.	At a regularly scheduled clinical appointment, approximately 2 hours
Primary	Measurement of urine osmolality as a laboratory biomarker of dehydration in SCD participants	Urine osmolality values <450 milliosmol/kg is considered abnormal in adults without fluid restrictions. It will be measured at 1 timepoint in 20 participants.	At a regularly scheduled clinical appointment, approximately 2 hours
Primary	Measurement of serum osmolality as a laboratory biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE	Serum osmolality values of >290 milliosmol/kg is considered abnormal. It will be measured at 1 timepoint in 10 participants.	During a VOC or VOE event before resuscitation therapy, approximately 2 hours
Primary	Measurement of serum osmolality as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE	Serum osmolality values of >290 milliosmol/kg is considered abnormal. It will be measured at 1 timepoint in 10 participants.	During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Primary	Measurement of hyperadhesion as a laboratory biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE	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.	During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours
Primary	Measurement of hyperadhesion as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE	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.	During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Primary	Measurement of elongation index as a cellular biomarker of dehydration before resuscitation therapy in SCD participants with VOC or VOE	Cellular dehydration marker, the elongation index, will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.	During a VOC or VOE event before fluid resuscitation, approximately 2 hours
Primary	Measurement of elongation index as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE	Cellular dehydration marker, the elongation index will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.	During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Primary	Measurement of point of sickling as a cellular biomarker of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE	Cellular dehydration marker, the elongation index will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.	During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours
Primary	Measurement of point of sickling as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE	Cellular dehydration marker, the elongation index will be measured by ektacytometry. It will be measured at 1 timepoint in 10 participants.	During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours
Primary	Measurement of urine osmolality as laboratory biomarkers of dehydration before fluid resuscitation therapy in SCD participants with VOC or VOE	Urine osmolality values <450 milliosmol/kg is considered abnormal in adults without fluid restrictions. It will be measured at 1 timepoint in 10 participants.	During a VOC or VOE event before fluid resuscitation therapy, approximately 2 hours
Primary	Measurement of urine osmolality as laboratory biomarkers of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE	Urine osmolality values <450 milliosmol/kg is considered abnormal in adults without fluid restrictions. It will be measured at 1 timepoint in 10 participants.	During a VOC or VOE event after fluid resuscitation therapy, approximately 2 hours