Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access

NCT03276494 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: 2017H0067
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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% hypertonic saline via IO.

Conditions

Stroke; Intracranial Hypotension; Cerebral Edema

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Tissue Damage

  Number of subjects with tissue damage (e.g. Myonecrosis, Skin necrosis, Extravasation, Compartment syndrome, Osteomyelitis). These data points will be determined by clinician assessment.

  24 hours

Secondary Outcomes (1)

• Pain Scale

  24 hours

Study Arms (1)

Intraosseous

OTHER

Administration of intraosseous hypertonic saline

Device: Intraosseous; Drug: Hypertonic saline

Interventions

Intraosseous DEVICE

Intraosseous administration of hypertonic saline

Intraosseous

Hypertonic saline DRUG

Intraosseous administration of hypertonic saline

Intraosseous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NCCU patients in which osmotherapy with HTS is planned (standard of care
• Does not already have a CVC or PICC.

You may not qualify if:

• \<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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Stroke; Intracranial Hypotension; Brain Edema

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Thomas Lawson
• Organization: Ohio State University

thomas.lawson@osumc.edu

614-366-7312

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Division of Cerebrovascular Disease and Neurocritical Care

Model Details: prospective case series

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: September 8, 2017
• Study Start: April 21, 2017
• Primary Completion: April 21, 2018
• Study Completion: April 21, 2018
• Last Updated: July 9, 2019
• Results First Posted: July 9, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

US (1)