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

Phase 4

Terminated

• Conditions: Dehydration
• Interventions: Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

• Registration Number: NCT01116102
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-30
• Study Start: 2010-05
• Primary Completion: 2010-05
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Study Completion: 2010-06
• Results First Submitted: 2011-09-12
• Results First Submitted QC: 2011-09-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-17
• Results First Posted: 2011-10-18
• Last Update Posted: 2011-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 ga catheter, no dose flush, up-titrated rate scheme	Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution	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.
25 ga needle, dose flush, up-titrated rate scheme	Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution	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.
25 ga needle, no dose flush, single-step rate scheme	Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution	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.
24 ga catheter, no dose flush, single-step rate scheme	Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution	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.
24 ga catheter, dose flush, single-step rate scheme	Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution	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.
24 ga catheter, dose flush, up-titrated rate scheme	Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution	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.
25 ga needle, dose flush, single-step rate scheme	Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution	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.
25 ga needle, no dose flush, up-titrated rate scheme	Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution	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.

Primary Outcome Measures

Name	Time	Method
Maximum Measured In-line Fluid Pressure	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	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

Name	Time	Method
Cumulative Fluid Volume Delivered	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
Technical Challenges Encountered During Fluid Infusion	at any occurence of a defined challenge or at end of infusion if no challenges occurred	Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems
Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement	end of catheter/needle placement

Trial Locations

Locations (1)

Kendle International, Inc. Drug Study Unit; 🇺🇸 Morgantown, West Virginia, United States