Phase 2
Completed N=6
Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access
Stroke · Intracranial Hypotension · Cerebral Edema
Source: ClinicalTrials.gov NCT03276494 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Subjects With Tissue Damage — 0 Participants
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% hypertonic saline via IO.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Tissue Damage |
— | — |
| SECONDARY Pain Scale |
— | — |
Eligibility Criteria
Inclusion Criteria
- NCCU patients in which osmotherapy with HTS is planned (standard of care
- Does not already have a CVC or PICC.
Exclusion Criteria
- <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
Data sourced from ClinicalTrials.gov (NCT03276494). 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.