Trial Outcomes & Findings for Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children (NCT NCT00477152)

NCT ID: NCT00477152

Last Updated: 2011-12-01

Results Overview

Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
• Results posted on: 2011-12-01

Participant Flow

Subjects recruited in emergency department after presenting with signs of mild to moderate dehydration

Participant milestones

Measure	HYLENEX-augmented Subcutaneous (SC) Rehydration Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Overall Study STARTED	52
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	HYLENEX-augmented Subcutaneous (SC) Rehydration Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Overall Study Parent withdrew consent	2
Overall Study Adverse Event	1

Baseline Characteristics

Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children

Baseline characteristics by cohort

Measure	HYLENEX-augmented Subcutaneous (SC) Rehydration n=51 Participants Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Age Continuous	1.91 years STANDARD_DEVIATION 1.949 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants
Age Categorical >= 2 months to < 3 years	43 participants n=5 Participants
Age Categorical >= 3 years to <= 10 years	8 participants n=5 Participants
Gorelick Dehydration Score	3.5 Number of moderate/severe symptoms STANDARD_DEVIATION 1.19 • n=5 Participants

PRIMARY outcome

Timeframe: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)

Population: ITT (all treated patients)

Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home

Outcome measures

Measure	HYLENEX-augmented Subcutaneous (SC) Rehydration n=51 Participants Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
HYLENEX-facilitated Subcutaneous (SC) Rehydration Success	43 participants

PRIMARY outcome

Timeframe: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)

Population: ITT (all treated patients)

Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination

Outcome measures

Measure	HYLENEX-augmented Subcutaneous (SC) Rehydration n=51 Participants Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success	48 participants

SECONDARY outcome

Timeframe: At end of placement of SC catheter

Population: ITT (all treated patients)

Outcome measures

Measure	HYLENEX-augmented Subcutaneous (SC) Rehydration n=51 Participants Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter 1 attempt	46 participants
Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter 2 attempts	5 participants

SECONDARY outcome

Timeframe: At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)

Population: ITT (all treated patients)

Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following 10 patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10.

Outcome measures

Measure	HYLENEX-augmented Subcutaneous (SC) Rehydration n=51 Participants Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Post-treatment Gorelick Dehydration Score Actual Score	0.5 No. moderate/severe symptoms (max = 10) Standard Deviation 0.9
Post-treatment Gorelick Dehydration Score Change from Baseline	-3.0 No. moderate/severe symptoms (max = 10) Standard Deviation 1.2

Adverse Events

HYLENEX-augmented Subcutaneous (SC) Rehydration

Serious events: 1 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Measure	HYLENEX-augmented Subcutaneous (SC) Rehydration n=51 participants at risk Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Infections and infestations Infusion site cellulitis	2.0% 1/51 • Number of events 1

Other adverse events

Measure	HYLENEX-augmented Subcutaneous (SC) Rehydration n=51 participants at risk Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
General disorders Infusion site erythema	86.3% 44/51
General disorders Infusion site haemorrhage	3.9% 2/51
General disorders Infusion site pain	90.2% 46/51
General disorders Infusion site rash	3.9% 2/51
General disorders Infusion site swelling	100.0% 51/51
General disorders Pyrexia	3.9% 2/51
Gastrointestinal disorders Vomiting	3.9% 2/51

Additional Information

George Harb, MD, MPH

Baxter Halthcare Corporation

Email: george_harb@baxter.com

Results disclosure agreements

• Principal investigator is a sponsor employee Baxter's agreements with PIs vary per individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of results communications (eg, for confidential information) up to 90 days prior to submission or communication. Baxter may request an additional delay of up to 60 days (eg, to allow for intellectual property protection).
• Publication restrictions are in place

Restriction type: OTHER