Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)

NCT01120431 | Withdrawn Phase 4

• 1 other identifier: 1838-008
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.

Conditions

Dehydration

Keywords

dehydration; fluid therapy; hyaluronoglucosaminidase; hyaluronidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; hyaluronan; rHuPH20; pediatric; ORT

Outcome Measures

Primary Outcomes (1)

• Total resource utilization in the ED

  2 to 8 hours

Secondary Outcomes (7)

• Rate of successful rehydration in the ED

  2 to 8 hours

• Time to ED discharge

  2 to 8 hours

• Amount of rehydration fluid administered

  2 to 8 hours

• Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver

  2 to 8 hours

• Occurrence of infusion site pain or other local reactions

  2 to 8 hours

Study Arms (2)

Oral rehydration therapy

ACTIVE COMPARATOR

Other: Oral rehydration fluid

hylenex-facilitated SC hydration

EXPERIMENTAL

Drug: Isotonic hydration fluid and recombinant human hyaluronidase

Interventions

Oral rehydration fluid OTHER

Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes

Also known as: oral rehydration salts

Oral rehydration therapy

Isotonic hydration fluid and recombinant human hyaluronidase DRUG

Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid

Also known as: hyelenx, rHuPH20, Lactated Ringer's solution, normal saline solution, 0.9% sodium chloride solution

hylenex-facilitated SC hydration

Eligibility Criteria

• Age: 2 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female and aged 2 months to 2 years
• Presenting to ED with mild or moderate dehydration
• Candidate for both parenteral and oral rehydration therapies
• Healthy, except for underlying etiology for dehydration
• Naive to ORT or having received attempted ORT at home for current occurrence of dehydration.
• Pre-dehydration body weight greater than 5th percentile for age

You may not qualify if:

• Severe dehydration
• Shock or a life-threatening situation
• Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion
• Medical reason or condition precluding administration of ORT
• Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study
• Anticipated need for hospitalization(other than for rehydration)
• Known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
• Known hyponatremia, hypernatremia or hypokalemia
• Medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration
• Participation in an investigational drug or device study within 30 days before participation in this study

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Halozyme Therapeutics: collaborator

MeSH Terms

Conditions

Dehydration

Interventions

Fluid Therapy; Ringer's Lactate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• George Harb, MD, MPH

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 11, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 8, 2017

Record last verified: 2017-05