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Phase 1 Completed N=18 Treatment

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

Disaster Medicine · Difficult Intravenous Access · Dehydration
Source: ClinicalTrials.gov NCT00740727 ↗
Enrolled (actual)
18
Serious AEs
—
Results posted
Sep 2009
Primary outcomePrimary: Number of Participants With Successfully Placed EASI Lines — 18 Participants

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).

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Successfully Placed EASI Lines		 18 —
PRIMARY
Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose		 18 —
SECONDARY
Number of Participants With Pain During EASI Infusion		 2 —
SECONDARY
Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up		 — —

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00740727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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