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

NCT00740727 | Completed Phase 1 Results

• 1 other identifier: EASI Access II
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Disaster Medicine; Difficult Intravenous Access; Dehydration

Keywords

Disaster; Mass casualty incident; Prehospital; Rehydration; Intravascular access

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of Participants With Pain During EASI Infusion

  1 day

• Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up

  2 days

Study Arms (1)

EASI

EXPERIMENTAL

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); Procedure: Enzymatically Augmented Subcutaneous Infusion (EASI) line placement

Interventions

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.

EASI

Human recombinant hyaluronidase (HRH) DRUG

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

Also known as: Hylenex

EASI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (12)

• 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.

  PMID: 16525142 BACKGROUND

• 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.

  PMID: 12113366 BACKGROUND

• 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.

  PMID: 16876899 BACKGROUND

• 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.

  PMID: 18095810 BACKGROUND

• 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.

  PMID: 8105720 BACKGROUND

• 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.

  PMID: 12670856 BACKGROUND

• 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.

  PMID: 17127123 BACKGROUND

• 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.

  PMID: 15605914 BACKGROUND

• 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.

  PMID: 2956050 BACKGROUND

• 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.

  PMID: 1742011 BACKGROUND

• 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.

  PMID: 17683255 BACKGROUND

• 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.

  PMID: 22854002 DERIVED

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephen H. Thomas MD MPH
• Organization: Massachusetts General Hospital

stephen-thomas@ouhsc.edu

6177267622

Study Officials

• Stephen H Thomas, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 25, 2008
• Study Start: February 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 11, 2009
• Results First Posted: September 11, 2009

Record last verified: 2009-09

Locations

US (1)