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

Hyponatremia Clinical Trial

— NaCrICh  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301274
• Other study ID #: HGNPE-20-2011
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: March 6, 2012
• Start date: February 2011
• Est. completion date: November 2011

Study information

• Verified date: March 2012
• Source: Hospital General de Niños Pedro de Elizalde
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Hyponatremia

Intervention

Drug:
• hypotonic
0.45% NaCl/5% dextrose IV maintenance fluids
• isotonic
0.9% NaCl/5% dextrose IV maintenance fluids

Locations

Country	Name	City	State
Argentina	Hospital General de Niños Pedro de Elizalde	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Niños Pedro de Elizalde

Country where clinical trial is conducted

Argentina, 

References & Publications (4)

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. — View 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. Epub 2006 Jun 5. Review. — View Citation

Eulmesekian PG, Pérez 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Mortality at 28 Days	Mortality in both groups will be compared 28 days after admission	28 days after admission	Yes
Secondary	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	Yes
Secondary	ICU Length of Stay	ICU length of stay (in days)	180 days	Yes