Continuous Intraosseous Vascular Access Over 48 Hours

Completed · Not applicable

Conditions studied: Intraosseous Vascular Access

In brief

A prospective study to determine the safety of intraosseous (IO) access for a period up to 48 hours in healthy adult volunteers and volunteers with a history of mild to moderate renal disease and/or controlled diabetes.

Key facts

Study ID

NCT01866475

Run by

Vidacare Corporation

People needed

127

Starts

2014-11-01

Expected to finish

2016-07-01

Last updated by the study team

2024-04-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 21 years or older
• 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

You may not qualify if…

• Imprisoned
• 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

Where it is running

• ICON Early Phase Services — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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