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

NCT01139294 | Completed Phase 4 Results DMC

• 2 other identifiers: 091087Clinical Trial
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dehydration; Cardiac Output; Pediatrics

Keywords

cardiac output; dehydration; pediatrics

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Gorelick Assessment

  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.

Study Arms (2)

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

Drug: Hylenex

Interventions

Hylenex DRUG

1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours

Also known as: hyaluronidase human injection

Hylenex

Eligibility Criteria

• Age: 2 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• patients presenting to the Emergency Department (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

You may not qualify if:

• patient in shock or a life-threatening situation
• immunocompromised, history of abscess or cellulitis, abscess \&/or cellulitis caused by Methicillin-resistant Staphylococcus aureus (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 milliequivalents per liter (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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232-9001, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study data was lost.Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location.

Results Point of Contact

• Title: Thomas Abramo, MD
• Organization: Vanderbilt University Medical Center

tjabramo@uams.edu

Study Officials

• Thomas J Abramo, MD

  Monroe Carell Jr. Children's Hospital at Vanderbilt

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 8, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 1, 2018
• Results First Posted: June 26, 2017

Record last verified: 2018-01

Locations

US (1)