Trial Outcomes & Findings for Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children (NCT NCT01251770)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

78 participants

Primary outcome timeframe

Change from baseline in sodium level after 12 hours

Results posted on

2017-03-03

Participant milestones
Measure	ClNa 0.3% maintenance solution with ClNa 0.3%	ClNa 0.45% maintenance solution with ClNa 0.45%
Overall Study STARTED	42	36
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	13	7

Reasons for withdrawal
Measure	ClNa 0.3% maintenance solution with ClNa 0.3%	ClNa 0.45% maintenance solution with ClNa 0.45%
Overall Study Protocol Violation	13	7

Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children

Baseline characteristics by cohort
Measure	ClNa 0.3% n=42 Participants maintenance solution with ClNa 0.3%	ClNa 0.45% n=36 Participants maintenance solution with ClNa 0.45%	Total n=78 Participants Total of all reporting groups
Age, Categorical <=18 years	42 Participants n=5 Participants	36 Participants n=7 Participants	78 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	105.6 months STANDARD_DEVIATION 35.1 • n=5 Participants	94.4 months STANDARD_DEVIATION 42.2 • n=7 Participants	100.5 months STANDARD_DEVIATION 38.7 • n=5 Participants
Gender Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Gender Male	28 Participants n=5 Participants	23 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment Argentina	42 participants n=5 Participants	36 participants n=7 Participants	78 participants n=5 Participants

Timeframe: Change from baseline in sodium level after 12 hours

Outcome measures
Measure	ClNa 0.3% n=42 Participants maintenance solution with ClNa 0.3%	ClNa 0.45% n=36 Participants maintenance solution with ClNa 0.45%
Change in Sodium Levels Natremia baseline	139.9 mEq/L Standard Deviation 3.4	138.1 mEq/L Standard Deviation 3.6
Change in Sodium Levels Natremia at 12 hours	138.1 mEq/L Standard Deviation 3.4	138.2 mEq/L Standard Deviation 4.0

Timeframe: 12 hours from baseline

Outcome measures
Measure	ClNa 0.3% n=29 Participants maintenance solution with ClNa 0.3%	ClNa 0.45% n=29 Participants maintenance solution with ClNa 0.45%
IV Fluid Intake	1434 ml Standard Deviation 444	1448 ml Standard Deviation 344

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events
Measure	ClNa 0.3% n=29 participants at risk maintenance solution with ClNa 0.3%	ClNa 0.45% n=29 participants at risk maintenance solution with ClNa 0.45%
Nervous system disorders nervous system disorders	0.00% 0/29 • until hospital discharge, average 5 days	0.00% 0/29 • until hospital discharge, average 5 days

Other adverse events
Measure	ClNa 0.3% n=29 participants at risk maintenance solution with ClNa 0.3%	ClNa 0.45% n=29 participants at risk maintenance solution with ClNa 0.45%
Metabolism and nutrition disorders hyponatremia	6.9% 2/29 • Number of events 2 • until hospital discharge, average 5 days	17.2% 5/29 • Number of events 5 • until hospital discharge, average 5 days
Metabolism and nutrition disorders hypernatremia	3.4% 1/29 • Number of events 1 • until hospital discharge, average 5 days	3.4% 1/29 • Number of events 1 • until hospital discharge, average 5 days

Hospital General de Niños Pedro de Elizalde

Phone: 00541143632100