Hospital General de Niños Pedro de Elizalde
Buenos Aires, Argentina
NCT Number: NCT01301274
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.
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Notify Me1 month–18 year
All sexes
Interventional
Not applicable
Buenos Aires, Argentina
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.45% NaCl/5% dextrose IV maintenance fluids
Other names: half saline/5% dextrose
0.9% NaCl/5% dextrose IV maintenance fluids
Other names: normal saline/5% dextrose
Time frame: 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
Time frame: 28 days after admission
Mortality in both groups will be compared 28 days after admission
Time frame: 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.
Time frame: 180 days
ICU length of stay (in days)
Hospital General de Niños Pedro de Elizalde
Other
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
Acronym: NaCrICh
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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