Trial · NCT01251770
Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
NCT01251770, Phase 3, Completed, Hospital General de Niños Pedro de Elizalde; results first posted 2012-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children. Trials, record NCT01251770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01251770
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
- NCT number
- NCT01251770
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 78 participants, actual
- Lead sponsor
- Hospital General de Niños Pedro de Elizalde
- Conditions
- Hyponatremia
- Interventions
- 0.45% NaCl/dextrose 5%, 0.3% NaCl/dextrose 5%
- First posted
- 2010-12-02
- Last updated
- 2017-03-03
- Results first posted
- 2012-01-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Sodium Levels | Change from baseline in sodium level after 12 hours | |
| Secondary | IV Fluid Intake | 12 hours from baseline |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Sodium Levels | Change from baseline in sodium level after 12 hours | mEq/L | MEAN | |
| SECONDARY | IV Fluid Intake | 12 hours from baseline | ml | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Sodium Levels | ClNa 0.3% | Natremia baseline | 139.9 | Standard Deviation 3.4 | mEq/L |
| Change in Sodium Levels | ClNa 0.45% | Natremia baseline | 138.1 | Standard Deviation 3.6 | mEq/L |
| Change in Sodium Levels | ClNa 0.3% | Natremia at 12 hours | 138.1 | Standard Deviation 3.4 | mEq/L |
| Change in Sodium Levels | ClNa 0.45% | Natremia at 12 hours | 138.2 | Standard Deviation 4.0 | mEq/L |
| IV Fluid Intake | ClNa 0.3% | 1434 | Standard Deviation 444 | ml | |
| IV Fluid Intake | ClNa 0.45% | 1448 | Standard Deviation 344 | ml |
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 | ClNa 0.3% | 42 | |
| Overall Study | STARTED | ClNa 0.45% | 36 | |
| Overall Study | COMPLETED | ClNa 0.3% | 29 | |
| Overall Study | COMPLETED | ClNa 0.45% | 29 | |
| Overall Study | NOT COMPLETED | ClNa 0.3% | 13 | |
| Overall Study | NOT COMPLETED | ClNa 0.45% | 7 |
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 | hyponatremia | Metabolism and nutrition disorders | ClNa 0.3% | 2 | 29 | 2 |
| other | hyponatremia | Metabolism and nutrition disorders | ClNa 0.45% | 5 | 29 | 5 |
| other | hypernatremia | Metabolism and nutrition disorders | ClNa 0.3% | 1 | 29 | 1 |
| other | hypernatremia | Metabolism and nutrition disorders | ClNa 0.45% | 1 | 29 | 1 |
| serious | nervous system disorders | Nervous system disorders | ClNa 0.3% | 0 | 29 | 0 |
| serious | nervous system disorders | Nervous system disorders | ClNa 0.45% | 0 | 29 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ClNa 0.3% | ||
| Total, all-cause mortality | ClNa 0.45% | ||
| Total, other adverse events | ClNa 0.3% | 2 | 29 |
| Total, other adverse events | ClNa 0.45% | 5 | 29 |
| Total, serious adverse events | ClNa 0.3% | 0 | 29 |
| Total, serious adverse events | ClNa 0.45% | 0 | 29 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ClNa 0.3% vs ClNa 0.45%: serious adverse events |
Source 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/NCT01251770
GET https://conductscience.org/api/trials/v1/NCT01251770/registered