Status:
COMPLETED
Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access
Lead Sponsor:
Ohio State University
Conditions:
Stroke
Intracranial Hypotension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Hypertonic saline is used to treat elevated intracranial pressure. Intraosseous vascular access has been used to administer fluids and medications. This study combines these to administer 3% hypertoni...
Detailed Description
HTS is used to mitigate and temporize intracranial pressure (ICP) elevations and cerebral edema by creating an osmotic gradient across the cell wall. HTS is part of the elevated ICP algorithm in the e...
Eligibility Criteria
Inclusion
- NCCU patients in which osmotherapy with HTS is planned (standard of care
- Does not already have a CVC or PICC.
Exclusion
- \<18 years old
- Known pregnancy
- Long bone fracture in the targeted site
- Proximity to prosthetic joint
- Excessive tissue/absence of anatomical landmarks
- History of osteopetrosis
- Previous significant orthopedic procedure at site
- Prosthetic limb or joint
- IO catheter use in the past 48 hours of the target bone
- Infection at the area of insertion
- Hypersensitivity to lidocaine
Key Trial Info
Start Date :
April 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03276494
Start Date
April 21 2017
End Date
April 21 2018
Last Update
July 9 2019
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210