Back to resultsEASI Access II --- Follow-up Study to the EASI Access Trial
Primary Purpose
Disaster Medicine, Difficult Intravenous Access, Dehydration
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Human recombinant hyaluronidase (HRH)
Enzymatically Augmented Subcutaneous Infusion (EASI) line placement
Sponsored by
About this trial
This is an interventional treatment trial for Disaster Medicine focused on measuring Disaster, Mass casualty incident, Prehospital, Rehydration, Intravascular access
Eligibility 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EASI
Arm Description
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.)
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT00740727
First Posted
August 21, 2008
Last Updated
September 10, 2009
Sponsor
Massachusetts General Hospital
Collaborators
Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00740727
Brief Title
EASI Access II --- Follow-up Study to the EASI Access Trial
Official Title
Enzymatically Augmented Subcutaneous Infusion (EASI) Access II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Baxter Healthcare Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disaster Medicine, Difficult Intravenous Access, Dehydration
Keywords
Disaster, Mass casualty incident, Prehospital, Rehydration, Intravascular access
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EASI
Arm Type
Experimental
Arm Description
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.)
Intervention Type
Drug
Intervention Name(s)
Human recombinant hyaluronidase (HRH)
Other Intervention Name(s)
Hylenex
Intervention Description
150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water)
Intervention Type
Procedure
Intervention Name(s)
Enzymatically Augmented Subcutaneous Infusion (EASI) line placement
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants With Successfully Placed EASI Lines
Description
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).
Time Frame
1 day
Title
Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of Participants With Pain During EASI Infusion
Description
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.
Time Frame
1 day
Title
Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up
Description
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).
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen H Thomas, MD MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16525142
Citation
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.
Results Reference
background
PubMed Identifier
12113366
Citation
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.
Results Reference
background
PubMed Identifier
16876899
Citation
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.
Results Reference
background
PubMed Identifier
18095810
Citation
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.
Results Reference
background
PubMed Identifier
8105720
Citation
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.
Results Reference
background
PubMed Identifier
12670856
Citation
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.
Results Reference
background
PubMed Identifier
17127123
Citation
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.
Results Reference
background
PubMed Identifier
15605914
Citation
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.
Results Reference
background
PubMed Identifier
2956050
Citation
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.
Results Reference
background
PubMed Identifier
1742011
Citation
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.
Results Reference
background
PubMed Identifier
17683255
Citation
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.
Results Reference
background
PubMed Identifier
22854002
Citation
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.
Results Reference
derived
Learn more about this trial
EASI Access II --- Follow-up Study to the EASI Access Trial
We'll reach out to this number within 24 hrs