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Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access

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ClinicalTrials.gov Identifier: NCT03276494
Recruitment Status : Completed
First Posted : September 8, 2017
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Archana Hinduja, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Stroke Intracranial Hypotension Cerebral Edema Device: Intraosseous Drug: Hypertonic saline Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective case series
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraosseous Administration of Hypertonic Saline in Acute Brain-injured Patients: A Prospective Case Series and Literature Review
Actual Study Start Date : April 21, 2017
Actual Primary Completion Date : April 21, 2018
Actual Study Completion Date : April 21, 2018

Arm Intervention/treatment
Intraosseous
Administration of intraosseous hypertonic saline
Device: Intraosseous
Intraosseous administration of hypertonic saline

Drug: Hypertonic saline
Intraosseous administration of hypertonic saline




Primary Outcome Measures :
  1. Number of Subjects With Tissue Damage [ Time Frame: 24 hours ]
    Number of subjects with tissue damage (e.g. Myonecrosis, Skin necrosis, Extravasation, Compartment syndrome, Osteomyelitis). These data points will be determined by clinician assessment.


Secondary Outcome Measures :
  1. Pain Scale [ Time Frame: 24 hours ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276494


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
  Study Documents (Full-Text)

Documents provided by Archana Hinduja, Ohio State University:
Study Protocol  [PDF] June 11, 2019
No Statistical Analysis Plan (SAP) exists for this study.


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Responsible Party: Archana Hinduja, Assistant Professor Division of Cerebrovascular Disease and Neurocritical Care, Ohio State University
ClinicalTrials.gov Identifier: NCT03276494     History of Changes
Other Study ID Numbers: 2017H0067
First Posted: September 8, 2017    Key Record Dates
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: manuscript on the case series has been submitted
Supporting Materials: Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Brain Edema
Intracranial Hypotension
Hypotension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases