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

Overview

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).

Full Title of Study: “Enzymatically Augmented Subcutaneous Infusion (EASI) Access II Trial”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: March 2009

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.

Arms, Groups and Cohorts

• Experimental: EASI
  • 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.)

Clinical Trial Outcome Measures

Primary Measures

• Number of Participants With Successfully Placed EASI Lines
  • Time Frame: 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
  • Time Frame: 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 Measures

• Number of Participants With Pain During EASI Infusion
  • Time Frame: 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
  • Time Frame: 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Massachusetts General Hospital
• Collaborator
  • Baxter Healthcare Corporation
• Provider of Information About this Clinical Study
  • Stephen H. Thomas MD MPH, Massachusetts General Hospital/Harvard Medical School
• Overall Official(s)
  • Stephen H Thomas, MD MPH, Principal Investigator, Massachusetts General Hospital

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