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

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

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 Overview

• Status: Completed
• Conditions: Hyponatremia
• Intervention / Treatment: Drug: hypotonic; Drug: isotonic

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Hospital General de Niños Pedro de Elizalde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Hospital General de Niños Pedro de Elizalde
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 18, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 7, 2012
• Last Update Submitted That Met QC Criteria: March 6, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: pediatrics; hyponatremia; maintenance solutions
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: HGNPE-20-2011