Study Results
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View full resultsBasic Information
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COMPLETED
NA
127 participants
INTERVENTIONAL
2014-11-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Renal Disease
Those with mild to moderate renal disease and had an EZ-IO for 48 hours
EZ-IO
To have an EZ-IO placed up to 48 hours
Diabetes
Those with controlled diabetes and had an EZ-IO for 48 hours
EZ-IO
To have an EZ-IO placed up to 48 hours
Renal disease and diabetes
Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours
EZ-IO
To have an EZ-IO placed up to 48 hours
Healthy adults
Those who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours
EZ-IO
To have an EZ-IO placed up to 48 hours
Interventions
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EZ-IO
To have an EZ-IO placed up to 48 hours
Eligibility Criteria
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Inclusion Criteria
* Self Identifying as having poor vascular access
* Healthy or Having at least one of the following conditions:
* Controlled diabetes, as evidenced by a glycosylated hemoglobin A1c (HbA1c) value of less than or equal to 8% at the time of screening. or
* Renal disease, Stages 1 to 3, as evidenced by the presence of albuminuria at the time of screening. Subjects albumin-creatinine ratio (ACR) must fall within the microalbuminuria or macroalbuminuria values: Microalbuminuria - ACR 17-250 mcg/mg for men; 25-355 mcg/mg for women or, Macroalbuminuria- ACR \>250 mcg/mg for men; \>355 mcg/mg for women
Exclusion Criteria
* Self identifying as pregnant
* Cognitively impaired
* Fracture in target bone
* Excessive tissue and/or absence of adequated anatomical landmarks in target bone
* Signs and symptoms of infection in target area
* IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
* Intravenous infusion within the past 30 days
* Current use of anti-coagulants
* Previous adverse reaction or known allergy to Lidocaine
* Current cardiac condition requiring pacemaker
* Currently taking beta blockers or calcium channel blockers for heart arrhythmia (use of beta blockers or calcium channel blocker for hypertension is allowed when indication of hypertension can be confirmed by physician
* Previous surgery for peripheral arterial disease
* History of ulcers to the extremities
* History of bilateral lymph node dissection in the arms or legs
* Known sickle-cell disease
* signs or symptoms of vascular disease or vascular insufficiencies to the extremities, as identified upon physical examination
* History of peripheral vascular disease
* Hyperkalemia as evidenced by potassium level greater than 5.1 mmol/L the upper limit of hte normal reference range at screening
21 Years
ALL
Yes
Sponsors
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Vidacare Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Emanuel DeNoia, MD
Role: PRINCIPAL_INVESTIGATOR
ICON Early Phase Services
Locations
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ICON Early Phase Services
San Antonio, Texas, United States
Countries
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Other Identifiers
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2011-16
Identifier Type: -
Identifier Source: org_study_id
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