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

Enzymatically Augmented Subcutaneous Infusion (EASI) Access II 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).

Study Overview

• Status: Completed
• Conditions: Disaster Medicine; Dehydration; Difficult Intravenous Access
• Intervention / Treatment: Drug: Human recombinant hyaluronidase (HRH); Procedure: Enzymatically Augmented Subcutaneous Infusion (EASI) line placement

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successfully Placed EASI Lines	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).	1 day
Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Pain During EASI Infusion	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.	1 day
Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up	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).	2 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Baxter Healthcare Corporation

Publications and helpful links

General Publications

• Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. doi: 10.1111/j.1553-2712.2003.tb01355.x.
• Sever MS, Vanholder R, Lameire N. Management of crush-related injuries after disasters. N Engl J Med. 2006 Mar 9;354(10):1052-63. doi: 10.1056/NEJMra054329. No abstract available.
• Stafford PW, Blinman TA, Nance ML. Practical points in evaluation and resuscitation of the injured child. Surg Clin North Am. 2002 Apr;82(2):273-301. doi: 10.1016/s0039-6109(02)00006-3.
• Bookbinder LH, Hofer A, Haller MF, Zepeda ML, Keller GA, Lim JE, Edgington TS, Shepard HM, Patton JS, Frost GI. A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release. 2006 Aug 28;114(2):230-41. doi: 10.1016/j.jconrel.2006.05.027. Epub 2006 Jun 7.
• Thomas JR, Yocum RC, Haller MF, von Gunten CF. Assessing the role of human recombinant hyaluronidase in gravity-driven subcutaneous hydration: the INFUSE-LR study. J Palliat Med. 2007 Dec;10(6):1312-20. doi: 10.1089/jpm.2007.0126.
• Beylot M, David F, Brunengraber H. Determination of the 13C-labeling pattern of glutamate by gas chromatography-mass spectrometry. Anal Biochem. 1993 Aug 1;212(2):532-6. doi: 10.1006/abio.1993.1364.
• Alam HB, Rhee P. New developments in fluid resuscitation. Surg Clin North Am. 2007 Feb;87(1):55-72, vi. doi: 10.1016/j.suc.2006.09.015.
• Dalal S, Bruera E. Dehydration in cancer patients: to treat or not to treat. J Support Oncol. 2004 Nov-Dec;2(6):467-79, 483.
• Craig AS, Eikenberry EF, Parry DA. Ultrastructural organization of skin: classification on the basis of mechanical role. Connect Tissue Res. 1987;16(3):213-23. doi: 10.3109/03008208709006977.
• Laurent UB, Dahl LB, Reed RK. Catabolism of hyaluronan in rabbit skin takes place locally, in lymph nodes and liver. Exp Physiol. 1991 Sep;76(5):695-703. doi: 10.1113/expphysiol.1991.sp003536.
• Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv. 2007 Jul;4(4):427-40. doi: 10.1517/17425247.4.4.427.
• Soremekun OA, Shear ML, Connolly J, Stewart CE, Thomas SH. Basic-level emergency medical technician administration of fluids and glucose via enzyme-assisted subcutaneous infusion access. Prehosp Disaster Med. 2012 Jun;27(3):220-5. doi: 10.1017/S1049023X12000829.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: August 21, 2008
• First Submitted That Met QC Criteria: August 22, 2008
• First Posted (Estimate): August 25, 2008

Study Record Updates

• Last Update Posted (Estimate): September 11, 2009
• Last Update Submitted That Met QC Criteria: September 10, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Disaster; Mass casualty incident; Prehospital; Rehydration; Intravascular access
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: EASI Access II