ClinicalTrials.gg
CompletedNCT03276494Updated Jul 9, 2019Results posted

Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access

A Phase 2 interventional study of Intraosseous and Hypertonic saline in Stroke, Intracranial Hypotension and Cerebral Edema, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-09.

Sponsored by Ohio State University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Stroke by Ohio State University — 1 open to participants now, 1 under way, none of them phase 3. Stroke · Ohio State University.

Started
2017
with 1 other
Phase 2
Only one
of the 13
Registered
7th of 13
by date

Among the 13 studies in Stroke by Ohio State University, this one is one of 2 that started in 2017, is the only one in phase 2, and was the 7th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

No phase7 · 1 open
Observational4 · 0 open
Phase 2this study1 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2003; this study’s year is marked. 2 started in 2017.

What they test

Size and results

Median enrollment 31 across the 9 interventional studies, 61 across the 4 observational. Of the 12 that completed or were terminated, 4 (33%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies in Stroke by Ohio State University, or all of them as a file.
02

Study 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.

Read the 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 emergency neurologic life support protocols HTS is superior to mannitol which is the alternate osmotherapy agent . HTS is typically administered via central vascular access due to the concern that if extravasation of the infusion occurs, tissue damage from cell implosion can occur

The IO route is generally accepted in resuscitation environments including the emergency department, EMS, and military settings with some authors recommending the IO as a primary method of obtaining emergency vascular access The adult advanced cardiac life support (ACLS) guidelines recommend either intravenous or IO access.

A number of studies have established the safety of IO administration of hypertonic solutions. Randomized adult pigs to IO 7.5% HTS, IO 3% HTS, and 0.9% isotonic saline and found regular tissue morphology, no necrosis or microscopic ischemic changes in the HTS groups. Several studies conducted to evaluate the efficacy of hypertonic solutions on resuscitation for hemorrhagic shock used the IO route and did not make note of problems arising from the administration of IO HTS. Another study using a canine model of hemorrhagic shock briefly mentioned transient lameness in the IO HTS group, but this resolved by 48 hours . While the majority of studies using hypertonic saline solutions did not make note of complications, one study induced hemorrhagic shock in dehydrated swine and resuscitated one group with 7.5% HTS and noted a high rate of local complications from soft tissue and bone marrow necrosis .

One study noted a subgroup of patients in which IO access was obtained on conscious patients. None of the patients received local anesthetic and none reported pain during insertion. Eighteen of the 22 conscious patients reported pain during fluid administration. Central venous catheter (CVC) placement is the current standard of care; even with local anesthesia it can be painful. Most of the potential subjects, due to the nature of their severe neurologic injury, may not be affected by the pain associated with IO fluid administration. Manufacturer literature suggests the use of lidocaine to anesthetize the bone before infusing if possible (Teleflex).

It is expected that utilizing IO for vascular access in the ICU will be safe and tolerable. If this study confirms the anticipated results, there are numerous implications. First, neurologically injured patients requiring emergent HTS may have faster access to this therapy. A study comparing IO to CVC access undergoing resuscitation in the emergency department found IO to be faster to insert (2.3 vs. 9.9 minutes) and had fewer failures to access on the first attempt. Second, serious complications from IO were absent compared with severe to life-threatening mechanical complications from CVC including pneumothorax, damage to the carotid artery, and bleeding which were cited at 0.7%-2.1% depending on site. And thirdly, central line associated blood stream infections (CLABSI) are a leading cause of hospital acquired infections in the ICU and are associated with higher mortality. CLABSI rates are measured by number of infections per 1,000 catheter days and shorter CVC dwell time is prudent. If a reliable and rapid source of vascular access could postpone or eliminate CVC insertion, risk of CLABSI may be reduced. These potential benefits outweigh the minimal expected risk.

03

Conditions studied

  • Stroke
  • Intracranial Hypotension
  • Cerebral Edema
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
  • to lidocaine
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Other
    Intraosseous

    Administration of intraosseous hypertonic saline

    Device: Intraosseous · Drug: Hypertonic saline

Interventions

  • DeviceIntraosseous

    Intraosseous administration of hypertonic saline

  • DrugHypertonic saline

    Intraosseous administration of hypertonic saline

06

What researchers measure

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.

    Time frame: 24 hours

Secondary outcomes

  1. Pain Scale

    Pain (CPOT-critical care pain observation tool). All non-verbal subjects have pain assessed with a CPOT score, as observed by clinicians. The CPOT is a validated pain score for nonverbal patients. This tool assesses pain with nonverbal indicators, adding 1-2 points for several nonverbal indicators of pain, 0 if the nonverbal indicator is absent, and is reported as a total summed score. It ranges from 0-8, with 0 indicating no pain and 8 indicating high pain. No patients were verbal, so the numeric pain rating scale was not used for any patients.

    Time frame: 24 hours

07

Results

Posted Jul 9, 2019

Participant flow

Participant flow — Overall Study
MilestoneIntraosseous
Started6
Completed5
Not completed1

Outcome measures

PrimaryNumber 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.

Time frame:
24 hours
Reported as:
Count of participants · Participants
Number of Subjects With Tissue Damage
ParticipantsIntraosseous
Number of Subjects With Tissue Damage0
SecondaryPain Scale

Pain (CPOT-critical care pain observation tool). All non-verbal subjects have pain assessed with a CPOT score, as observed by clinicians. The CPOT is a validated pain score for nonverbal patients. This tool assesses pain with nonverbal indicators, adding 1-2 points for several nonverbal indicators of pain, 0 if the nonverbal indicator is absent, and is reported as a total summed score. It ranges from 0-8, with 0 indicating no pain and 8 indicating high pain. No patients were verbal, so the numeric pain rating scale was not used for any patients.

Time frame:
24 hours
Reported as:
Median · units on a scale
Pain Scale
units on a scaleIntraosseous
Pain Scale0 (0 to 6)

Adverse events

Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intraosseous0/5 (0%)0/5 (0%)0/5 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Intraosseous
<=18 years0
Between 18 and 65 years4
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Intraosseous
Female1
Male4
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intraosseous
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American2
White2
More than one race0
Unknown or Not Reported1
08

Study locations

1 site
  • The Ohio State University
    Columbus, Ohio 43210, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — manuscript on the case series has been submitted

Supporting information: Clinical study report

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2017 to primary completion in Apr 2018, 12 months.

Results were first posted in Jul 2019, 1 year 2 months after primary completion.

Of 113 non-industry phase 2 interventional studies under Stroke, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's 12 months is below that.

Counting every sponsor, half of 133 studies reached it within 40 months; a quarter within 24 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2017
First posted
Sep 8, 2017
StartActual
Apr 21, 2017
Primary completionActual
Apr 21, 2018
CompletionActual
Apr 21, 2018
Results first posted
Jul 9, 2019
Last update
Jul 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03276494
Responsible party
Archana Hinduja (Assistant Professor Division of Cerebrovascular Disease and Neurocritical Care, Ohio State University) — Principal investigator
First posted
Sep 8, 2017
Start date
Apr 21, 2017
Primary completion
Apr 21, 2018
Completion
Apr 21, 2018
Results posted
Jul 9, 2019
Last update
Jul 9, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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