Phase 3
Completed N=78
Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
Source: ClinicalTrials.gov NCT01251770 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Change in Sodium Levels — 139.9; 138.1; 138.1; 138.2 mEq/L — p=0.030
Summary
The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sodium Levels |
139.9; 138.1; 138.1; 138.2 | 0.030 sig |
| SECONDARY IV Fluid Intake |
1434; 1448 | 0.895 |
Eligibility Criteria
Inclusion Criteria
- Postsurgical children admitted to HGNPE Department of Surgery between january 2010 and october 2011.
Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid administration is anticipated to be intravenous, in the first 12 hours following surgery.
Informed consent of parent/guardian.
Exclusion Criteria
- • Children with illness that have primary fluid and electrolyte imbalance such as:
- Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia ( 3 seconds), hypotension (BP 180 mg/ dl.
- Require ICU admission.
- Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification.
- Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
- Patients with known pre-existing risk of PNa derangements: DI or SIADH
Data sourced from ClinicalTrials.gov (NCT01251770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.