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Completed

NCT Number: NCT00740727

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

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).

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Key information

Conditions

Disaster Medicine Dehydration Difficult Intravenous Access Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Human recombinant hyaluronidase (HRH)

Drug

150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water)

Other names: Hylenex

Enzymatically Augmented Subcutaneous Infusion (EASI) line placement

Procedure

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.

Primary outcomes

  1. 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).

  2. 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 outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

Enzymatically Augmented Subcutaneous Infusion (EASI) Access II Trial

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2008
Registry last updated
Sep 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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