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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00740727
First received: August 21, 2008
Last updated: September 10, 2009
Last verified: September 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Disaster Medicine
Difficult Intravenous Access
Dehydration
 Drug: Human recombinant hyaluronidase (HRH)
Procedure: Enzymatically Augmented Subcutaneous Infusion (EASI) line placement
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enzymatically Augmented Subcutaneous Infusion (EASI) Access II Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Participants With Successfully Placed EASI Lines [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Pain During EASI Infusion [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)
 Drug: Human recombinant hyaluronidase (HRH)
150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water)
Other Name: Hylenex
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740727

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Baxter Healthcare Corporation
Investigators
Principal Investigator: Stephen H Thomas, MD MPH Massachusetts General Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stephen H. Thomas MD MPH, Massachusetts General Hospital/Harvard Medical School
ClinicalTrials.gov Identifier: NCT00740727     History of Changes
Other Study ID Numbers: EASI Access II
Study First Received: August 21, 2008
Results First Received: March 3, 2009
Last Updated: September 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Disaster
Mass casualty incident
Prehospital
Rehydration
Intravascular access

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013