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Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 29, 2017
First Posted Date  ICMJE September 8, 2017
Results First Submitted Date  ICMJE May 10, 2019
Results First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE April 21, 2017
Actual Primary Completion Date April 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
Tissue damage [ Time Frame: 24 hours ]
Myonecrosis, Skin necrosis, Extravasation, Compartment syndrome, Osteomyelitis. These data points will be determined by clinician assessment.
Change History Complete list of historical versions of study NCT03276494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
Pain [ Time Frame: 24 hours ]
Subjectively tolerable levels of pain/discomfort. Pain (0-10 numeric scale or CPOT-critical care pain observation tool). If patients are verbal they will be asked to quantify their pain with the numeric score. If the patient is non-verbal, a CPOT score will be determined by clinicians.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access
Official Title  ICMJE Intraosseous Administration of Hypertonic Saline in Acute Brain-injured Patients: A Prospective Case Series and Literature Review
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
prospective case series
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Intracranial Hypotension
  • Cerebral Edema
Intervention  ICMJE
  • Device: Intraosseous
    Intraosseous administration of hypertonic saline
  • Drug: Hypertonic saline
    Intraosseous administration of hypertonic saline
Study Arms  ICMJE Intraosseous
Administration of intraosseous hypertonic saline
Interventions:
  • Device: Intraosseous
  • Drug: Hypertonic saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2018)
6
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2017)
10
Actual Study Completion Date  ICMJE April 21, 2018
Actual Primary Completion Date April 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03276494
Other Study ID Numbers  ICMJE 2017H0067
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: manuscript on the case series has been submitted
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Archana Hinduja, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ohio State University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP