Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics (Hylenex)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01139294
First received: June 4, 2010
Last updated: June 7, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Dehydration
Cardiac Output
Pediatrics
Drug: hyaluronidase human injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Cardiac output trends [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • gorelick assessment [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

    Gorelick assessment of hydration status at baseline, and at the end of sub-q or IV hydration treament 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


Estimated Enrollment: 75
Study Start Date: February 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard IV therapy
control arm of the study
Active Comparator: Hylenex sub-q
Patients receiving Hylenex subcutaneous are in the experimental group being compared to the control of standard IV
Drug: hyaluronidase human injection
1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours
Other Name: Hylenex recombinant

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients presenting to the ED with moderate dehydration (gorelick dehydration classification : presence of 3-6 moderate signs and symptoms) requiring parenteral rehydration.
  • Patient has not successfully received oral or IV fluids immediately prior to enrollment
  • patient's legally authorized representative has signed the informed consent and is willing for the patient to receive Hylenex augmented sub-q rehydration

Exclusion Criteria:

  • patient in shock or a life-threatening situation
  • immunocompromised, history of abscess or cellulitis, abscess &/or cellulitis caused by MRSA, family history of abscess or cellulitis
  • requires IV therapy for another indication
  • has an indwelling catheter
  • has already received rehydration therapy by IV route within the last 48 hours or substantial oral fluid in the immediate time period of enrollment
  • has a condition precluding sub-q injection or infusion site evaluation in the upper middle back area or at another elected site of infusion
  • has a reason for hospital admission or extended ED stay other than dehydration
  • has an known hypersensitivity to hyaluronidase or another ingredient in the formulation of Hylenex
  • has a know hyponatremia < 130 mEq/L or hypernatremia >155 mEq/L
  • has a know hypokalemia <3.0 mEq/L
  • has a medical condition likely to interfere with the patients ability to fully complete the study protocol or the ability to have the protocol-specified assessments
  • has a medical history, screening physical exam finding or historical clinical lab result that in the opinion of the investigator would preclude the patients safe participation in the is study or which might adversely effect the interpretation of the study results
  • patient participated in a study of any investigational drug or device within 230 days prior to enrollment in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139294

Locations
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232-9001
Sponsors and Collaborators
Vanderbilt University
Baxter Healthcare Corporation
Investigators
Principal Investigator: Thomas J Abramo, MD Monroe Carell Jr. Children's Hospital at Vanderbilt
  More Information

No publications provided

Responsible Party: Thomas Abramo, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01139294     History of Changes
Other Study ID Numbers: 091087, Clinical Trial
Study First Received: June 4, 2010
Last Updated: June 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
cardiac output
dehydration
pediatrics

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014