Trial Outcomes & Findings for Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia (NCT NCT01909336)
NCT ID: NCT01909336
Last Updated: 2016-12-16
Results Overview
Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
161 participants
Primary outcome timeframe
8 hours
Results posted on
2016-12-16
Participant Flow
This trial was conducted in the paediatric and emer- gency departments of the Hospital Regional Materno Infantil de Alta Especialidad in Nuevo Leon, Mexico between August 2013 and February 2014.
Participant milestones
| Measure |
Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)
Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
|
Group 2: 0.45% Saline in 5% Dextrose (Intravenous)
Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
|
Group 3: 0.9% Saline in 5% Dextrose (Intravenous)
Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
55
|
|
Overall Study
COMPLETED
|
49
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
Reasons for withdrawal
| Measure |
Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)
Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
|
Group 2: 0.45% Saline in 5% Dextrose (Intravenous)
Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
|
Group 3: 0.9% Saline in 5% Dextrose (Intravenous)
Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
Baseline Characteristics
Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
Baseline characteristics by cohort
| Measure |
Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)
n=49 Participants
Group 1: 0.3% Saline in 3.3% dextrose (intravenous)
0.3% Saline in 3.3% dextrose: Hypotonic Solutions: 0.3% Saline in 3.3% dextrose
|
Group 2: 0.45% Saline in 5% Dextrose (Intravenous)
n=50 Participants
Group 2: 0.45% Saline in 5% dextrose (intravenous)
0.45% Saline in 5% dextrose: Hypotonic Solutions: 0.45% Saline in 5% dextrose
|
Group 3: 0.9% Saline in 5% Dextrose (Intravenous)
n=52 Participants
Group 3: 0.9% Saline in 5% dextrose (intravenous)
0.9% Saline in 5% dextrose: Isotonic Solutions 0.9% Saline in 5% dextrose
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.5 months
STANDARD_DEVIATION 56.1 • n=5 Participants
|
54.6 months
STANDARD_DEVIATION 55.9 • n=7 Participants
|
58.8 months
STANDARD_DEVIATION 57.7 • n=5 Participants
|
58.9 months
STANDARD_DEVIATION 56.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Dehydration (mild), n
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
10 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Systolic blood pressure, mmHg
|
101.1 mmHg
STANDARD_DEVIATION 11.2 • n=5 Participants
|
99.4 mmHg
STANDARD_DEVIATION 9 • n=7 Participants
|
99.8 mmHg
STANDARD_DEVIATION 11.4 • n=5 Participants
|
100.1 mmHg
STANDARD_DEVIATION 10.5 • n=4 Participants
|
|
Heart rate, bpm
|
124 bpm
STANDARD_DEVIATION 25 • n=5 Participants
|
126 bpm
STANDARD_DEVIATION 29 • n=7 Participants
|
128 bpm
STANDARD_DEVIATION 28 • n=5 Participants
|
126 bpm
STANDARD_DEVIATION 27 • n=4 Participants
|
|
Serum sodium, mmol/L
|
135 mmol/L
STANDARD_DEVIATION 2.8 • n=5 Participants
|
135.8 mmol/L
STANDARD_DEVIATION 3.1 • n=7 Participants
|
135.8 mmol/L
STANDARD_DEVIATION 3.2 • n=5 Participants
|
135.5 mmol/L
STANDARD_DEVIATION 3 • n=4 Participants
|
|
Serum osmolarity, mOsm/L
|
277.4 mOsm/L
STANDARD_DEVIATION 10.6 • n=5 Participants
|
278 mOsm/L
STANDARD_DEVIATION 16.2 • n=7 Participants
|
281.4 mOsm/L
STANDARD_DEVIATION 9.5 • n=5 Participants
|
279 mOsm/L
STANDARD_DEVIATION 8.6 • n=4 Participants
|
|
Normonatremic, n
|
30 participants
n=5 Participants
|
34 participants
n=7 Participants
|
34 participants
n=5 Participants
|
98 participants
n=4 Participants
|
|
Hyponatraemia, n
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Hypernatremic, n
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 hoursSerum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study
Outcome measures
| Measure |
Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)
n=30 Participants
Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
|
Group 2: 0.45% Saline in 5% Dextrose (Intravenous)
n=34 Participants
Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
|
Group 3: 0.9% Saline in 5% Dextrose (Intravenous)
n=34 Participants
Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
|
|---|---|---|---|
|
Hospital Acquired Hyponatremia
|
10 participants
|
11 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 8 hourshyponatraemia (defined as serum sodium \< 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium \> 145 mmol/L)
Outcome measures
| Measure |
Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)
n=49 Participants
Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
|
Group 2: 0.45% Saline in 5% Dextrose (Intravenous)
n=50 Participants
Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
|
Group 3: 0.9% Saline in 5% Dextrose (Intravenous)
n=52 Participants
Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
|
|---|---|---|---|
|
Dysnatraemias at T8
Normonatremia
|
26 participants
|
30 participants
|
47 participants
|
|
Dysnatraemias at T8
Hyponatremia
|
23 participants
|
20 participants
|
3 participants
|
|
Dysnatraemias at T8
Hypernatremia
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 8 hoursAdjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours
Outcome measures
| Measure |
Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)
n=49 Participants
Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
|
Group 2: 0.45% Saline in 5% Dextrose (Intravenous)
n=50 Participants
Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
|
Group 3: 0.9% Saline in 5% Dextrose (Intravenous)
n=52 Participants
Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
|
|---|---|---|---|
|
Adverse Reactions Attributed to Acute Plasma Sodium Changes
|
12 Minor Adverse Reactions
|
13 Minor Adverse Reactions
|
11 Minor Adverse Reactions
|
Adverse Events
Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 2: 0.45% Saline in 5% Dextrose (Intravenous)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 3: 0.9% Saline in 5% Dextrose (Intravenous)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)
n=49 participants at risk
Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
|
Group 2: 0.45% Saline in 5% Dextrose (Intravenous)
n=50 participants at risk
Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
|
Group 3: 0.9% Saline in 5% Dextrose (Intravenous)
n=52 participants at risk
Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/52
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
3/49 • Number of events 3
|
8.0%
4/50 • Number of events 4
|
5.8%
3/52 • Number of events 3
|
|
General disorders
Fever
|
8.2%
4/49 • Number of events 4
|
18.0%
9/50 • Number of events 9
|
7.7%
4/52 • Number of events 4
|
|
General disorders
Drowsiness
|
4.1%
2/49 • Number of events 2
|
0.00%
0/50
|
3.8%
2/52 • Number of events 2
|
|
General disorders
Dehydration
|
4.1%
2/49 • Number of events 2
|
0.00%
0/50
|
3.8%
2/52 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place