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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Baxter Healthcare Corporation

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.