Trial Outcomes & Findings for Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics (NCT NCT01139294)
NCT ID: NCT01139294
Last Updated: 2018-02-01
Results Overview
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
COMPLETED
PHASE4
17 participants
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.
2018-02-01
Participant Flow
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.
Participant milestones
| Measure |
Standard of Care IV Therapy
control arm of the study
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
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0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 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.Population: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.Population: 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.
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. * volume of fluid infuse over time * time to discharge from ED to home or transfer into the hospital * discharge diagnosis from ED * duration of any supplemental hospitalization for supplemental hydration * time to first urine output observed * requirement for rescue therapy and nature of the rescue therapy * incidence of readmission to hospital/ED * global assessment of overall satisfaction with rehydration therapy by parents and caregiver
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care IV Therapy
Hylenex
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place