Phase 1
N=18
EASI Access II --- Follow-up Study to the EASI Access Trial
Disaster Medicine · Difficult Intravenous Access · Dehydration
Bottom Line
View on ClinicalTrials.gov: NCT00740727 ↗Enrolled (actual)
18
Serious AEs
—
Results posted
Sep 2009
Primary outcome: Primary: Number of Participants With Successfully Placed EASI Lines — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Human recombinant hyaluronidase (HRH) (Drug); Enzymatically Augmented Subcutaneous Infusion (EASI) line placement (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successfully Placed EASI Lines |
18 | — |
| PRIMARY Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose |
18 | — |
| SECONDARY Number of Participants With Pain During EASI Infusion |
2 | — |
| SECONDARY Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up |
— | — |
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).
Eligibility Criteria
Inclusion Criteria
- Subjects will be at least 18 years of age and have none of the following conditions:
- pregnancy (negative urine pregnancy test to be performed before study participation),
- diabetes, or coagulopathic (including taking any anticoagulants);
- Subjects cannot be taking steroids or other immunosuppressants.
- Because of the potential for reduced hyaluronidase effectiveness, the study excludes patients taking more than 80 mg daily aspirin, as well as any patients taking ACTH, antihistamines, or estrogen other than in oral contraceptive preparations.
- Subjects will not be required to fast before the study, but will not allowed to eat or drink during the EASI infusion or the phlebotomy sampling time frame.
Data sourced from ClinicalTrials.gov (NCT00740727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.