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| ID | Type | Description | Link |
|---|---|---|---|
| Clinical Trial | Other Grant/Funding Number | Baxter |
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and electrolytes compared to intravenous methods.
This is an open-labeled, single-center Phase IV clinical trial. The study will consist of patients with moderate hypovolemia/dehydration requiring parenteral rehydration. It is expected that this study will describe the onset or change in cardiac output using Hylenex augmented subcutaneous rehydration from ages 2 months up to 3 years and at a flow rate satisfying clinical needs, especially in reference to changes in cardiac output observed in standard intravenous rehydration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard IV therapy | No Intervention | control arm of the study | |
| Hylenex | Experimental | 1ml subcutaneous with initiation of intravenous fluids then every 24 hours with a maximum dose of 3 injections in 72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hylenex | Drug | 1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output Trends | Describe the cardiac output trends measured in liters per minute (onset and changes in slope over time) by noninvasively monitoring methods in pediatric patients being rehydrated by Hylenex augmented subcutaneous rehydration or routine IV rehydration | Measurements and data are recorded only while patient is receiving care in the Emergency Department (ED). A f/u call is made on day 3 and/or day 7 post enrollment into the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Gorelick Assessment | Gorelick assessment of hydration status at baseline, and at the end of sub-q or IV hydration treatment or at discharge from the emergency dept.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Abramo, MD | Monroe Carell Jr. Children's Hospital at Vanderbilt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232-9001 | United States |
17 participants were enrolled into the study per the final report to the Institutional Review Board. Actual study data was lost, so arm assignments are unknown.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care IV Therapy | control arm of the study |
| FG001 | Hylenex | 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No baseline data available. Study data was lost. Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care IV Therapy | control arm of the study |
| BG001 | Hylenex | 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cardiac Output Trends | Describe the cardiac output trends measured in liters per minute (onset and changes in slope over time) by noninvasively monitoring methods in pediatric patients being rehydrated by Hylenex augmented subcutaneous rehydration or routine IV rehydration | No outcome measure data available. Study data was lost. Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location. | Posted | Measurements and data are recorded only while patient is receiving care in the Emergency Department (ED). A f/u call is made on day 3 and/or day 7 post enrollment into the study. |
|
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No adverse event data available. Study data was lost. Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care IV Therapy | control arm of the study |
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Study data was lost.Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Abramo, MD | Vanderbilt University Medical Center | tjabramo@uams.edu |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| Measurements and data are recorded only while patient is receiving care in the ED. A f/u call is made on day 3 and/or day 7 post enrollment into the study. |
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours |
|
| Secondary | Gorelick Assessment | Gorelick assessment of hydration status at baseline, and at the end of sub-q or IV hydration treatment or at discharge from the emergency dept.
| No outcome measure data available. Study data was lost.Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location. | Posted | Measurements and data are recorded only while patient is receiving care in the ED. A f/u call is made on day 3 and/or day 7 post enrollment into the study. |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Hylenex | 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours Hylenex: 1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours | 0 | 0 | 0 | 0 |
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| D013568 | Pathological Conditions, Signs and Symptoms |