Phase 2 N=6 Treatment

Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access

Stroke · Intracranial Hypotension · Cerebral Edema

Bottom Line

View on ClinicalTrials.gov: NCT03276494 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Number of Subjects With Tissue Damage — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Intraosseous (Device); Hypertonic saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ohio State University
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Tissue Damage	—	—
SECONDARY Pain Scale	—	—

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.

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

View full record on ClinicalTrials.gov →

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.