Trial Outcomes & Findings for Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial (NCT NCT00734214)
NCT ID: NCT00734214
Last Updated: 2015-04-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
258 participants
Primary outcome timeframe
During the treatment and follow-up period.
Results posted on
2015-04-29
Participant Flow
Participant milestones
| Measure |
0.9% NaCl
|
0.45% NaCl
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
130
|
|
Overall Study
COMPLETED
|
124
|
126
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
0.9% NaCl
|
0.45% NaCl
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
MD withdrawal
|
1
|
0
|
Baseline Characteristics
Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial
Baseline characteristics by cohort
| Measure |
0.9% NaCl
n=128 Participants
|
0.45% NaCl
n=130 Participants
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
128 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
258 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
|
9.2 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
9.2 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
9.2 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
128 participants
n=5 Participants
|
130 participants
n=7 Participants
|
258 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the treatment and follow-up period.Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: during the study interventionPopulation: Intention to treat analysis
Plasma sodium less than 135 mmol/L
Outcome measures
| Measure |
0.9% NaCl
n=128 Participants
|
0.45% NaCl
n=130 Participants
|
|---|---|---|
|
Hyponatremia
|
29 participants
|
53 participants
|
SECONDARY outcome
Timeframe: During the treatment and follow-up periodOutcome measures
Outcome data not reported
Adverse Events
0.9% NaCl
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
0.45% NaCl
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.9% NaCl
n=128 participants at risk
|
0.45% NaCl
n=130 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Generalized edema
|
0.00%
0/128
|
0.00%
0/130
|
|
Blood and lymphatic system disorders
New onset hypertension
|
0.00%
0/128
|
0.00%
0/130
|
Other adverse events
| Measure |
0.9% NaCl
n=128 participants at risk
|
0.45% NaCl
n=130 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Generalized Edema
|
7.0%
9/128 • Number of events 9
|
6.2%
8/130 • Number of events 10
|
|
Blood and lymphatic system disorders
New onset Hypertension
|
0.00%
0/128
|
1.5%
2/130 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place