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

Mass General Brigham

Status and phase: Completed; Phase 1

Conditions: Dehydration; Difficult Intravenous Access; Disaster Medicine

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00740727

EASI Access II

Details and patient eligibility

About

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).

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

EASI

Experimental group

Description:

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.)

Treatment:

Procedure: Enzymatically Augmented Subcutaneous Infusion (EASI) line placement

Drug: Human recombinant hyaluronidase (HRH)