Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A) - Full Text View

Purpose

The purpose is to characterize the in-line pressure profiles associated with several infusion technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded by recombinant human hyaluronidase (hylenex). The safety and tolerability of hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated.

Condition	Intervention	Phase
Dehydration	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique 1A Study (INFUSE-AT 1A): A Randomized, Parallel Group Study to Evaluate the In-line Pressure, Flow Rate, Safety and Tolerability of Hylenex-facilitated Subcutaneous Fluid Administration In Healthy Volunteers Using Various Subcutaneous Infusion Techniques

Resource links provided by NLM:

MedlinePlus related topics: Dehydration

Drug Information available for: Ringer's lactate Hyaluronidase Hyaluronidase (Human recombinant)

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Maximum Measured In-line Fluid Pressure [ Time Frame: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion ] [ Designated as safety issue: No ]
Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion

Secondary Outcome Measures:

Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement [ Time Frame: end of catheter/needle placement ] [ Designated as safety issue: No ]
Cumulative Fluid Volume Delivered [ Time Frame: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion ] [ Designated as safety issue: No ]
Technical Challenges Encountered During Fluid Infusion [ Time Frame: at any occurence of a defined challenge or at end of infusion if no challenges occurred ] [ Designated as safety issue: No ]
Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems

Enrollment:	20
Study Start Date:	May 2010
Study Completion Date:	June 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 24 ga catheter, dose flush, single-step rate scheme Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution Other Names: rHuPH20 LR solution
Experimental: 24 ga catheter, no dose flush, single-step rate scheme Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution Other Names: rHuPH20 LR solution
Experimental: 24 ga catheter, dose flush, up-titrated rate scheme Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution Other Names: rHuPH20 LR solution
Experimental: 24 ga catheter, no dose flush, up-titrated rate scheme Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution Other Names: rHuPH20 LR solution
Experimental: 25 ga needle, dose flush, single-step rate scheme Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution Other Names: rHuPH20 LR solution
Experimental: 25 ga needle, no dose flush, single-step rate scheme Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution Other Names: rHuPH20 LR solution
Experimental: 25 ga needle, dose flush, up-titrated rate scheme Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution Other Names: rHuPH20 LR solution
Experimental: 25 ga needle, no dose flush, up-titrated rate scheme Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution Other Names: rHuPH20 LR solution

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female, aged 18 to 60 years, inclusive.
Body mass index 19.0 to 35.0 kg/m2
Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on the upper back in the area intended for infusion
Free from any clinically significant abnormality on the basis of medical/medication history or physical examination
Vital signs and clinical laboratory parameters within normal range or, if outside normal range, deemed not clinically significant
Negative urine drug and alcohol screens.

Exclusion Criteria:

Upper back pathology that could interfere with study outcome.
History of congestive heart failure, known coronary heart disease, active or recent pulmonary disease, or renal insufficiency.
Rales on lung auscultation.
Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
Treatment with furosemide, benzodiazepines, or phenytoin.
Pregnancy or breastfeeding.
Exposure to any experimental drug within 30 days prior to study admission, or previous participation in this study.
Any other reason which, in the investigator's opinion, would prevent the safe participation in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116102

Locations

United States, West Virginia
Kendle International, Inc. Drug Study Unit
Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Baxter Healthcare Corporation

Halozyme Therapeutics

Investigators

Study Director:

George Harb, MD, MPH

Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT01116102 History of Changes
Other Study ID Numbers:	1838-009
Study First Received:	April 30, 2010
Results First Received:	September 12, 2011
Last Updated:	October 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Baxter Healthcare Corporation:

dehydration
fluid therapy
hyaluronoglucosaminidase
hyaluronidase
hypodermoclysis

clysis
subcutaneous hydration
subcutaneous rehydration
hyaluronan
rHuPH20

Additional relevant MeSH terms:

Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013