Trial Outcomes & Findings for Nebulized Hypertonic Saline for Mechanically Ventilated Children (NCT NCT01945944)

NCT ID: NCT01945944

Last Updated: 2016-06-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: typically 4 days - 2 weeks
• Results posted on: 2016-06-28

Participant Flow

Participant milestones

Measure	Placebo Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Overall Study STARTED	9	9
Overall Study COMPLETED	8	6
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Placebo Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Overall Study Adverse Event	0	2
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Nebulized Hypertonic Saline for Mechanically Ventilated Children

Baseline characteristics by cohort

Measure	Placebo n=9 Participants Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 Participants Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)	Total n=18 Participants Total of all reporting groups
Age, Continuous	26 weeks n=5 Participants	12.7 weeks n=7 Participants	17.9 weeks n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized African-American	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
PEEP (positive end-expiratory pressure)	5 cm-H20 n=5 Participants	7 cm-H20 n=7 Participants	6 cm-H20 n=5 Participants

PRIMARY outcome

Timeframe: typically 4 days - 2 weeks

Outcome measures

Measure	Placebo n=9 Participants Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 Participants Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Duration of Mechanical Ventilation	129.5 hours Interval 74.4 to 146.1	208.1 hours Interval 136.3 to 319.8

SECONDARY outcome

Timeframe: during mechanical ventilation (typically 4 days - 2 weeks)

using chest x ray score. The score measures the amount of lung collapse ("atelectasis") observed on a chest x-ray. For each of the 5 lung lobes, 1 point is given for linear atelectasis, 2 points for sub-segmental atelectasis and 3 points for lobar atelectasis. The range is 0-15 points, with higher scores reflecting more severe lung collapse.

Outcome measures

Measure	Placebo n=9 Participants Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 Participants Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Atelectasis	4.67 units on a scale Interval 3.92 to 6.0	4 units on a scale Interval 2.33 to 5.83

SECONDARY outcome

Timeframe: during mechanical ventilation (typically 4 days - 2 weeks)

as dichotomous outcome (yes/no) following drug administration

Outcome measures

Measure	Placebo n=9 Participants Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 Participants Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Wheezing	3 percentage of drug doses w/ wheezing	1 percentage of drug doses w/ wheezing

SECONDARY outcome

Timeframe: during hospitalization (typically 4 days - 2 weeks)

Outcome measures

Measure	Placebo n=9 Participants Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 Participants Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
ICU Length of Stay	8 days Interval 6.0 to 12.5	12 days Interval 9.0 to 17.0

SECONDARY outcome

Timeframe: during hospitalization (typically 4 days - 2 weeks)

Outcome measures

Measure	Placebo n=9 Participants Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 Participants Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Hospital Length of Stay	15 days Interval 9.0 to 22.5	17 days Interval 16.0 to 22.5

SECONDARY outcome

Timeframe: during hospitalization (typically 4 days - 2 weeks)

The baseline sodium was the last level measured prior to study initiation, typically within 24hrs of study initiation. The change in blood sodium level was calculated as the difference between the mean post-enrollment sodium level during ICU care and the sodium level at enrollment.

Outcome measures

Measure	Placebo n=9 Participants Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 Participants Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Change in Serum Sodium From Baseline	1 mEq/L Interval -0.9 to 6.7	-1.5 mEq/L Interval -4.1 to 7.1

SECONDARY outcome

Timeframe: during mechanical ventilation (typically 4 days - 2 weeks)

measured in ml/cm H20/kg using parameters on mechanical ventilator

Outcome measures

Measure	Placebo n=9 Participants Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 Participants Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Dynamic Compliance	6.52 mL/kg/cm-H20 Interval 4.21 to 8.14	4.47 mL/kg/cm-H20 Interval 2.94 to 7.0

SECONDARY outcome

Timeframe: during mechanical ventilation (typically 4 days - 2 weeks)

SaO2/FiO2. This is a measure of how will the lungs are providing oxygen to the body. Higher ratios reflect better lung function.

Outcome measures

Measure	Placebo n=9 Participants Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 Participants Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Oxygenation	239 ratio Interval 196.0 to 280.0	188 ratio Interval 162.0 to 239.0

SECONDARY outcome

Timeframe: during mechanical ventilation (typically 4 days - 2 weeks)

in % of tidal volume, using parameters on mechanical ventilator. Dead space is a measure of how much of the lung is not able to move air into and out of the body. Higher levels of dead space reflect higher levels of lung dysfunction.

Outcome measures

Measure	Placebo n=9 Participants Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 Participants Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Dead Space	29 percentage of lung volume Interval 20.0 to 37.0	37 percentage of lung volume Interval 26.0 to 45.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypertonic Saline

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=9 participants at risk Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days Placebo (0.9% saline)	Hypertonic Saline n=9 participants at risk Hypertonic saline (3%), 3mL every 6hrs for up to 7 days Hypertonic saline (3%)
Respiratory, thoracic and mediastinal disorders Desaturation (oxygen)	0.00% 0/9	22.2% 2/9 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Steven Shein, MD

Rainbow Babies and Children's Hospital

Phone: 216-844-3310

Email: drstevenshein@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place