We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00740727
First Posted: August 25, 2008
Last Update Posted: September 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Massachusetts General Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enzymatically Augmented Subcutaneous Infusion (EASI) Access II Trial

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Participants With Successfully Placed EASI Lines [ Time Frame: 1 day ]
  • Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose [ Time Frame: 1 day ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

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
First Submitted: August 21, 2008
First Posted: August 25, 2008
Results First Submitted: March 3, 2009
Results First Posted: September 11, 2009
Last Update Posted: September 11, 2009
Last Verified: September 2009

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