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

Dehydration Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01116102
• Other study ID #: 1838-009
• Status: Terminated
• Phase: Phase 4
• First received: April 30, 2010
• Last updated: October 17, 2011
• Start date: May 2010
• Est. completion date: June 2010

Study information

• Verified date: October 2011
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dehydration

Intervention

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

Locations

Country	Name	City	State
United States	Kendle International, Inc. Drug Study Unit	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Halozyme Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement		end of catheter/needle placement	No
Secondary	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	No
Secondary	Technical Challenges Encountered During Fluid Infusion	Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems	at any occurence of a defined challenge or at end of infusion if no challenges occurred	No