Trial · NCT01301274
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
NCT01301274, Not applicable, Completed, Hospital General de Niños Pedro de Elizalde; results first posted 2012-03-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children. Trials, record NCT01301274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01301274
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
- NCT number
- NCT01301274
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 66 participants, actual
- Lead sponsor
- Hospital General de Niños Pedro de Elizalde
- Conditions
- Hyponatremia
- Interventions
- hypotonic, isotonic
- First posted
- 2011-02-23
- Last updated
- 2012-03-07
- Results first posted
- 2012-03-07
- Limitations and caveats
- Limitations: Antidiuretic hormone were not measured.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Sodium Levels in Both Groups | first 48 hours | Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion |
| Secondary | Mortality at 28 Days | 28 days after admission | Mortality in both groups will be compared 28 days after admission |
| Secondary | Mechanical Ventilation Free Days at 28 Day of Admission | first 28 day after starting mechanical ventilation | mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero. |
| Secondary | ICU Length of Stay | 180 days | ICU length of stay (in days) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum Sodium Levels in Both Groups | first 48 hours | mEq/L | MEAN | |
| SECONDARY | Mortality at 28 Days | 28 days after admission | The analysis was per intention to treat | participants | NUMBER |
| SECONDARY | Mechanical Ventilation Free Days at 28 Day of Admission | first 28 day after starting mechanical ventilation | days | MEAN | |
| SECONDARY | ICU Length of Stay | 180 days | days | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serum Sodium Levels in Both Groups | Hypotonic Arm | 137.8 | Standard Deviation 4.3 | mEq/L | |
| Serum Sodium Levels in Both Groups | Isotonic Arm | 140.0 | Standard Deviation 4.1 | mEq/L | |
| Mortality at 28 Days | Hypotonic Arm | 3 | participants | ||
| Mortality at 28 Days | Isotonic Arm | 0 | participants | ||
| Mechanical Ventilation Free Days at 28 Day of Admission | Hypotonic Arm | 19.9 | Standard Deviation 7.9 | days | |
| Mechanical Ventilation Free Days at 28 Day of Admission | Isotonic Arm | 21.5 | Standard Deviation 6.6 | days | |
| ICU Length of Stay | Hypotonic Arm | 8.5 | Standard Deviation 5.5 | days | |
| ICU Length of Stay | Isotonic Arm | 11.9 | Standard Deviation 11.5 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hypotonic | 34 | |
| Overall Study | STARTED | Isotonic | 32 | |
| Overall Study | COMPLETED | Hypotonic | 32 | |
| Overall Study | COMPLETED | Isotonic | 31 | |
| Overall Study | NOT COMPLETED | Hypotonic | 2 | |
| Overall Study | NOT COMPLETED | Isotonic | 1 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Serum sodium < 135 mEq/l | General disorders | Hypotonic | 5 | 34 | 5 |
| other | Serum sodium < 135 mEq/l | General disorders | Isotonic | 4 | 32 | 4 |
| serious | hyponatremia <130 mEq/l | General disorders | Hypotonic | 1 | 34 | 1 |
| serious | hyponatremia <130 mEq/l | General disorders | Isotonic | 0 | 32 | 0 |
| serious | Death | General disorders | Hypotonic | 3 | 34 | 3 |
| serious | Death | General disorders | Isotonic | 0 | 32 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hypotonic | ||
| Total, all-cause mortality | Isotonic | ||
| Total, other adverse events | Hypotonic | 5 | 34 |
| Total, other adverse events | Isotonic | 4 | 32 |
| Total, serious adverse events | Hypotonic | 4 | 34 |
| Total, serious adverse events | Isotonic | 0 | 32 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hypotonic Arm vs Isotonic Arm: Mortality at 28 Days | Trial comparisons |
| Hypotonic vs Isotonic: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01301274
GET https://conductscience.org/api/trials/v1/NCT01301274/registered