EASI Access II --- Follow-up Study to the EASI Access Trial

Phase 1

Completed

Interventions: Drug: Human recombinant hyaluronidase (HRH)
Procedure: Enzymatically Augmented Subcutaneous Infusion (EASI) line placement

Brief 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).

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
EASI	Human recombinant hyaluronidase (HRH)	Subjects will undergo placement of EASI catheters. All subjects in whom EASI catheters are placed, will receive Human Recombinant Hyaluronidase (HRH) as part of the EASI placement. (No subject will receive HRH, other than as part of EASI catheter placement.)
EASI	Enzymatically Augmented Subcutaneous Infusion (EASI) line placement	Subjects will undergo placement of EASI catheters. All subjects in whom EASI catheters are placed, will receive Human Recombinant Hyaluronidase (HRH) as part of the EASI placement. (No subject will receive HRH, other than as part of EASI catheter placement.)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successfully Placed EASI Lines	1 day	Ability of Basic Life Support (BLS) providers to place EASI access lines. The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed).
Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose	1 day	Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Pain During EASI Infusion	1 day	Assessment during EASI placement \& initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.
Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up	2 days	Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3. Presence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back).