0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children (NaCrICh)
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|ClinicalTrials.gov Identifier: NCT01301274|
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : March 7, 2012
Last Update Posted : March 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hyponatremia||Drug: hypotonic Drug: isotonic||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
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
- Serum Sodium Levels in Both Groups [ 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
- Mortality at 28 Days [ Time Frame: 28 days after admission ]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 ]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 ]ICU length of stay (in days)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|