Clinical trial NCT01301274: 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyponatremia
Keywords: hyponatremia
maintenance solutions
pediatrics
Lead sponsor: Hospital General de Niños Pedro de Elizalde
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 66
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Serum Sodium Levels in Both Groups
timeFrame: first 48 hours
Secondary outcomes:
measure: Mortality at 28 Days
timeFrame: 28 days after admission
measure: Mechanical Ventilation Free Days at 28 Day of Admission
timeFrame: first 28 day after starting mechanical ventilation
measure: ICU Length of Stay
timeFrame: 180 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de Niños Pedro de Elizalde
Study officials:
affiliation: Hospital General de Niños Pedro de Elizalde
name: Facundo A Jorro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General de Niños Pedro de Elizalde
name: Gustavo De Baisi, MD
role: STUDY_DIRECTOR
affiliation: Hospital General de Niños Pedro de Elizalde
name: Susana Bengoa
role: PRINCIPAL_INVESTIGATOR
References:
citation: HOLLIDAY MA, SEGAR WE, LUKENBILL A, VALENCIA RM, DURELL AM. Variations in muscle electrolyte composition due to sampling and to aging. Proc Soc Exp Biol Med. 1957 Aug-Sep;95(4):786-8. doi: 10.3181/00379727-95-23364. No abstract available.
citation: Burrows FA, Shutack JG, Crone RK. Inappropriate secretion of antidiuretic hormone in a postsurgical pediatric population. Crit Care Med. 1983 Jul;11(7):527-31. doi: 10.1097/00003246-198307000-00009.
citation: Eulmesekian PG, Perez A, Minces PG, Bohn D. Hospital-acquired hyponatremia in postoperative pediatric patients: prospective observational study. Pediatr Crit Care Med. 2010 Jul;11(4):479-83. doi: 10.1097/PCC.0b013e3181ce7154.
citation: Choong K, Kho ME, Menon K, Bohn D. Hypotonic versus isotonic saline in hospitalised children: a systematic review. Arch Dis Child. 2006 Oct;91(10):828-35. doi: 10.1136/adc.2005.088690. Epub 2006 Jun 5.
citation: Jorro Baron FA, Meregalli CN, Rombola VA, Bolasell C, Pigliapoco VE, Bartoletti SE, Debaisi GE. Hypotonic versus isotonic maintenance fluids in critically ill pediatric patients: a randomized controlled trial. Arch Argent Pediatr. 2013 Jul-Aug;111(4):281-7. doi: 10.5546/aap.2013.eng.281. English, Spanish.