EASI Access II --- Follow-up Study to the EASI Access Trial
NCT00740727 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2009-09-11
Summary
Test whether Basic Life Support (BLS) providers can successfully place Enzymatically Augmented Subcutaneous Infusion (EASI) Access lines for subcutaneous infusion, and characterize intravascular absorption of EASI-administered (tracer-labelled) glucose (D5W).
Conditions
- Disaster Medicine
- Difficult Intravenous Access
- Dehydration
Interventions
- DRUG
-
Human recombinant hyaluronidase (HRH)
150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water)
- PROCEDURE
-
Enzymatically Augmented Subcutaneous Infusion (EASI) line placement
Subjects will under placement of an EASI line. This entails placement of a small (20-gauge) catheter in the upper back, in the subcutaneous space.
Sponsors & Collaborators
-
Baxter Healthcare Corporation
collaborator INDUSTRY -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Stephen H Thomas, MD MPH · Massachusetts General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-02-28
- Primary Completion
- 2009-03-31
- Completion
- 2009-03-31
Countries
- United States
Study Locations
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