Trial Outcomes & Findings for Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access (NCT NCT03276494)

Last Updated: 2019-07-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

24 hours

Results posted on

2019-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	Intraosseous Administration of intraosseous hypertonic saline Intraosseous: Intraosseous administration of hypertonic saline Hypertonic saline: Intraosseous administration of hypertonic saline
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intraosseous n=5 Participants Administration of intraosseous hypertonic saline Intraosseous: Intraosseous administration of hypertonic saline Hypertonic saline: Intraosseous administration of hypertonic saline
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intraosseous n=5 Participants Administration of intraosseous hypertonic saline Intraosseous: Intraosseous administration of hypertonic saline Hypertonic saline: Intraosseous administration of hypertonic saline
Number of Subjects With Tissue Damage	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intraosseous n=5 Participants Administration of intraosseous hypertonic saline Intraosseous: Intraosseous administration of hypertonic saline Hypertonic saline: Intraosseous administration of hypertonic saline
Pain Scale	0 units on a scale Interval 0.0 to 6.0

Adverse Events

Intraosseous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Lawson

Ohio State University

Phone: 614-366-7312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place