Cutaneous Hydration Assessment in Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Participants under 12-years old
- •Participants being treated with experimental therapies in clinical trials
结局指标
主要结局
Dermal water content measurements before fluid resuscitation in SCD participants with VOC or VOE
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 point of sickling as a cellular biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
时间窗: 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 hyperadhesion as a laboratory biomarker of dehydration after fluid resuscitation therapy in SCD participants with VOC or VOE
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Enrico Novelli
Associate Professor and Section Chief - Classical Hematology
University of Pittsburgh