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

NCT01301274 | Completed Results DMC

• 1 other identifier: HGNPE-20-2011
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyponatremia

Keywords

hyponatremia; maintenance solutions; pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mortality at 28 Days

  28 days after admission

• Mechanical Ventilation Free Days at 28 Day of Admission

  first 28 day after starting mechanical ventilation

• ICU Length of Stay

  180 days

Study Arms (2)

Hypotonic

ACTIVE COMPARATOR

Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.

Drug: hypotonic

Isotonic

EXPERIMENTAL

Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.

Drug: isotonic

Interventions

hypotonic DRUG

0.45% NaCl/5% dextrose IV maintenance fluids

Also known as: half saline/5% dextrose

Hypotonic

isotonic DRUG

0.9% NaCl/5% dextrose IV maintenance fluids

Also known as: normal saline/5% dextrose

Isotonic

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital General de Niños Pedro de Elizalde: lead

Study Sites (1)

Hospital General de Niños Pedro de Elizalde

Buenos Aires, Argentina

Location

Related Publications (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.

  PMID: 13465804 BACKGROUND

• 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.

  PMID: 6861500 BACKGROUND

• 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.

  PMID: 20124948 BACKGROUND

• 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.

  PMID: 16754657 BACKGROUND

• 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.

  PMID: 23912284 DERIVED

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Limitations: Antidiuretic hormone were not measured.

Results Point of Contact

• Title: Dr Facundo Jorro Barón
• Organization: Intensive Care Unit - Hospital Pedro de Elizalde

jorrobox@yahoo.com.ar

00541143632100

Study Officials

• Facundo A Jorro, MD

  Hospital General de Niños Pedro de Elizalde

  PRINCIPAL INVESTIGATOR

• Gustavo De Baisi, MD

  Hospital General de Niños Pedro de Elizalde

  STUDY DIRECTOR

• Susana Bengoa

  Hospital General de Niños Pedro de Elizalde

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 23, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 7, 2012
• Results First Posted: March 7, 2012

Record last verified: 2012-03

Locations

AR (1)