0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children (NaCrICh)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Controlled, Double Blinded, Clinical Trial: 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children|
- Serum Sodium Levels in Both Groups [ Time Frame: first 48 hours ] [ Designated as safety issue: Yes ]Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion
- Mortality at 28 Days [ Time Frame: 28 days after admission ] [ Designated as safety issue: Yes ]Mortality in both groups will be compared 28 days after admission
- Mechanical Ventilation Free Days at 28 Day of Admission [ Time Frame: first 28 day after starting mechanical ventilation ] [ Designated as safety issue: Yes ]mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.
- ICU Length of Stay [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]ICU length of stay (in days)
|Study Start Date:||February 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Hypotonic
Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
0.45% NaCl/5% dextrose IV maintenance fluids
Other Name: half saline/5% dextrose
Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
0.9% NaCl/5% dextrose IV maintenance fluids
Other Name: normal saline/5% dextrose
In patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. Since the original descriptions by Holliday and Segar, the recommended standard maintenance solutions are based on "physiological needs", containing 30-50 mEq/L of sodium.
However hyponatremia has become increasingly recognized in hospitalized children suggesting that Holliday and Segar's recommendations are frequently inappropriately applied.
It has been described augmented intersticial lung water in patients receiving hypotonic maintenance solutions. Also, hyponatremia has been demonstrated in post-surgery critically ill children receiving hypotonic maintenance solutions.
More over, non-physiologic antidiuretic hormone (ADH) secretion has been described in the great majority of hospitalized children due to nausea, stress, pain, and/or surgical interventions.
It has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance intravenous (IV) solution, to avoid the development of hyponatremia.
There are not studies in critically ill children evaluating the effect of isotonic solutions on sodium levels.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301274
|Hospital General de Niños Pedro de Elizalde|
|Buenos Aires, Argentina|
|Principal Investigator:||Facundo A Jorro, MD||Hospital General de Niños Pedro de Elizalde|
|Study Director:||Gustavo De Baisi, MD||Hospital General de Niños Pedro de Elizalde|
|Principal Investigator:||Susana Bengoa||Hospital General de Niños Pedro de Elizalde|