0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Hyponatremia

Intervention / Treatment
-----------------
* Drug: hypotonic
* Drug: isotonic


Participation Criteria
=================
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 <3 years old children, >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).

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypotonic<br>Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids. | Drug: hypotonic<br>* 0.45% NaCl/5% dextrose IV maintenance fluids<br>* Other names: half saline/5% dextrose;|
| Experimental: Isotonic<br>Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids. | Drug: isotonic<br>* 0.9% NaCl/5% dextrose IV maintenance fluids<br>* Other names: normal saline/5% dextrose;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Sodium Levels in Both Groups | Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion | first 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at 28 Days | Mortality in both groups will be compared 28 days after admission | 28 days after admission | 
| Mechanical Ventilation Free Days at 28 Day of Admission | mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero. | first 28 day after starting mechanical ventilation | 
| ICU Length of Stay | ICU length of stay (in days) | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyponatremia, maintenance solutions, pediatrics