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

Primary Purpose

Dehydration

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

About this trial

This is an interventional treatment trial for Dehydration focused on measuring dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kendle International, Inc. Drug Study Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

24 ga catheter, dose flush, single-step rate scheme

24 ga catheter, no dose flush, single-step rate scheme

24 ga catheter, dose flush, up-titrated rate scheme

24 ga catheter, no dose flush, up-titrated rate scheme

25 ga needle, dose flush, single-step rate scheme

25 ga needle, no dose flush, single-step rate scheme

25 ga needle, dose flush, up-titrated rate scheme

25 ga needle, no dose flush, up-titrated rate scheme

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Maximum Measured In-line Fluid Pressure

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

Cumulative Fluid Volume Delivered

Technical Challenges Encountered During Fluid Infusion

Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems

Full Information

NCT ID

NCT01116102

First Posted

April 30, 2010

Last Updated

October 17, 2011

Sponsor

Baxter Healthcare Corporation

Collaborators

Halozyme Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01116102

Brief Title

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

Acronym

INFUSE-AT1A

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Terminated

Why Stopped

Strategic business decision (not related to safety or efficacy concerns)

Study Start Date

May 2010 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baxter Healthcare Corporation

Collaborators

Halozyme Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dehydration

Keywords

dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

24 ga catheter, dose flush, single-step rate scheme

Arm Type

Experimental

Arm Description

Arm Title

24 ga catheter, no dose flush, single-step rate scheme

Arm Type

Experimental

Arm Description

Arm Title

24 ga catheter, dose flush, up-titrated rate scheme

Arm Type

Experimental

Arm Description

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.

Arm Title

24 ga catheter, no dose flush, up-titrated rate scheme

Arm Type

Experimental

Arm Description

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.

Arm Title

25 ga needle, dose flush, single-step rate scheme

Arm Type

Experimental

Arm Description

Arm Title

25 ga needle, no dose flush, single-step rate scheme

Arm Type

Experimental

Arm Description

Arm Title

25 ga needle, dose flush, up-titrated rate scheme

Arm Type

Experimental

Arm Description

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.

Arm Title

25 ga needle, no dose flush, up-titrated rate scheme

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

Other Intervention Name(s)

rHuPH20, LR solution

Intervention Description

Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

Primary Outcome Measure Information:

Title

Maximum Measured In-line Fluid Pressure

Description

Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion

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

Secondary Outcome Measure Information:

Title

Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement

Time Frame

end of catheter/needle placement

Title

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

Title

Technical Challenges Encountered During Fluid Infusion

Description

Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems

Time Frame

at any occurence of a defined challenge or at end of infusion if no challenges occurred

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George Harb, MD, MPH

Organizational Affiliation

Baxter Healthcare Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Kendle International, Inc. Drug Study Unit

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26505

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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