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Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access

Intraosseous Administration of Hypertonic Saline in Acute Brain-injured Patients: A Prospective Case Series and Literature Review

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03276494
Enrollment
6
Registered
2017-09-08
Start date
2017-04-21
Completion date
2018-04-21
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Intracranial Hypotension, Cerebral Edema

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.

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.

Interventions

Intraosseous administration of hypertonic saline

DRUGHypertonic saline

Intraosseous administration of hypertonic saline

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

prospective case series

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Subjects With Tissue Damage24 hoursNumber of subjects with tissue damage (e.g. Myonecrosis, Skin necrosis, Extravasation, Compartment syndrome, Osteomyelitis). These data points will be determined by clinician assessment.

Secondary

MeasureTime frameDescription
Pain Scale24 hoursPain (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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intraosseous
Administration of intraosseous hypertonic saline Intraosseous: Intraosseous administration of hypertonic saline Hypertonic saline: Intraosseous administration of hypertonic saline
5
Total5

Baseline characteristics

CharacteristicIntraosseous
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
2 Participants
Sex: Female, Male
Female
1 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 5
other
Total, other adverse events
0 / 5
serious
Total, serious adverse events
0 / 5

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
IntraosseousNumber of Subjects With Tissue Damage0 Participants
Secondary

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

ArmMeasureValue (MEDIAN)
IntraosseousPain Scale0 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026