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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stroke
Intracranial Hypotension
Cerebral Edema
Interventions Device: Intraosseous
Drug: Hypertonic saline
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intraosseous
Hide Arm/Group Description

Administration of intraosseous hypertonic saline

Intraosseous: Intraosseous administration of hypertonic saline

Hypertonic saline: Intraosseous administration of hypertonic saline

Period Title: Overall Study
Started 6
Completed 5
Not Completed 1
Arm/Group Title Intraosseous
Hide Arm/Group Description

Administration of intraosseous hypertonic saline

Intraosseous: Intraosseous administration of hypertonic saline

Hypertonic saline: Intraosseous administration of hypertonic saline

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  80.0%
>=65 years
1
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
1
  20.0%
Male
4
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  40.0%
White
2
  40.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  20.0%
1.Primary Outcome
Title Number of Subjects With Tissue Damage
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intraosseous
Hide Arm/Group Description:

Administration of intraosseous hypertonic saline

Intraosseous: Intraosseous administration of hypertonic saline

Hypertonic saline: Intraosseous administration of hypertonic saline

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Pain Scale
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intraosseous
Hide Arm/Group Description:

Administration of intraosseous hypertonic saline

Intraosseous: Intraosseous administration of hypertonic saline

Hypertonic saline: Intraosseous administration of hypertonic saline

Overall Number of Participants Analyzed 5
Median (Full Range)
Unit of Measure: units on a scale
0
(0 to 6)
Time Frame 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intraosseous
Hide Arm/Group Description

Administration of intraosseous hypertonic saline

Intraosseous: Intraosseous administration of hypertonic saline

Hypertonic saline: Intraosseous administration of hypertonic saline

All-Cause Mortality
Intraosseous
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Serious Adverse Events
Intraosseous
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intraosseous
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Lawson
Organization: Ohio State University
Phone: 614-366-7312
EMail: thomas.lawson@osumc.edu
Layout table for additonal information
Responsible Party: Archana Hinduja, Ohio State University
ClinicalTrials.gov Identifier: NCT03276494    
Other Study ID Numbers: 2017H0067
First Submitted: June 29, 2017
First Posted: September 8, 2017
Results First Submitted: May 10, 2019
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019