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

NCT01116102 | Terminated Phase 4 Results

• 1 other identifier: 1838-009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (3)

• Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement

  end of catheter/needle placement

• 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

Study Arms (8)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

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

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

Also known as: rHuPH20, LR solution

24 ga catheter, dose flush, single-step rate scheme; 24 ga catheter, dose flush, up-titrated rate scheme; 24 ga catheter, no dose flush, single-step rate scheme; 24 ga catheter, no dose flush, up-titrated rate scheme; 25 ga needle, dose flush, single-step rate scheme; 25 ga needle, dose flush, up-titrated rate scheme; 25 ga needle, no dose flush, single-step rate scheme; 25 ga needle, no dose flush, up-titrated rate scheme

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Halozyme Therapeutics: collaborator

Study Sites (1)

Kendle International, Inc. Drug Study Unit

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Dehydration

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Due to small numbers of subjects in each treatment arm, no conclusions can be drawn on the influence of any of the individual potential pressure-affecting factors or the combinations of these factors on in-line fluid pressure.

Results Point of Contact

• Title: George Harb, MD, MPH
• Organization: Baxter Healthcare Corporation

george_harb@baxter.com

Study Officials

• George Harb, MD, MPH

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 24, 2011
• Results First Posted: October 18, 2011

Record last verified: 2011-10

Locations

US (1)