N/A
N=66
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
Hyponatremia
Bottom Line
View on ClinicalTrials.gov: NCT01301274 ↗Enrolled (actual)
66
Serious AEs
6.1%
Results posted
Mar 2012
Primary outcome: Primary: Serum Sodium Levels in Both Groups — 137.8; 140.0 mEq/L — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- hypotonic (Drug); isotonic (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Hospital General de Niños Pedro de Elizalde
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Sodium Levels in Both Groups |
137.8; 140.0 | 0.04 sig |
| SECONDARY Mortality at 28 Days |
3; 0 | 0.081 |
| SECONDARY Mechanical Ventilation Free Days at 28 Day of Admission |
19.9; 21.5 | 0.396 |
| SECONDARY ICU Length of Stay |
8.5; 11.9 | 0.129 |
Summary
The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.
Eligibility Criteria
Inclusion Criteria
- Age 1 month to 18 years
- ICU stay >24 hours
- Normal seric sodium (135 - 145 mEq/L).
- Requirement of IV maintenance solutions >80% total fluids intake
Exclusion Criteria
- Patients with diagnoses of renal failure (serum creatinine >1 g/dl in 1,5 in >3 years), hepatic failure with ascitis and portal hypertension, adrenal failure, nephrotic - nephritic syndrome, Kawasaki disease, sickle cell anemia, Syndrome of inappropriate antidiuretic hormone secretion, diabetes insipidus,metabolic disease.
- Diuretics use in the first 48 hours thereafter indicated IV solutions.
- Plasma glucose is >200 mg%.
- Any patients requiring IV fluids therapy different that maintenance (total parenteral nutrition, hyperhydration).
Data sourced from ClinicalTrials.gov (NCT01301274). 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.