Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

Sepsis Clinical Trial

Official title:

Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457873
• Other study ID #: PED-06-016
• Status: Completed
• Phase: Phase 3
• Start date: January 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2022
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have serious complications. It has recently been suggested that isotonic saline may be a more appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support in order to:

Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial comparing these solutions.

Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of hyponatremia (Na <136 mmol/L) between patients receiving isotonic and hypotonic intravenous fluids at at least 50% of the traditional maintenance rate for an interval of at least 8 hours.

Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• 1 month to 18 years of age

• Require IV fluids for at least 8 hr.

• Baseline serum sodium >=136 mmol/L & <=145 mmol/L

Exclusion Criteria:

• Baseline serum sodium concentration less than 136 mmol/L or greater than 145 mmol/L

• Renal disease, a history of cardiac dysfunction or evidence of cardiac dysfunction, pre-existing hypertension, diuretic use, edema, or known adrenal dysfunction

• Acute neurological illness such as meningitis or encephalitis

• Severe chronic neurological illnesses (uncontrolled seizure disorders, severe developmental delay)

Related Conditions & MeSH terms

• Bronchiolitis
• Gastroenteritis
• Sepsis
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• 0.9% saline in 5% dextrose (intravenous)

• 0.45% saline in 5% dextrose (intravenous)

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Hoorn EJ, Geary D, Robb M, Halperin ML, Bohn D. Acute hyponatremia related to intravenous fluid administration in hospitalized children: an observational study. Pediatrics. 2004 May;113(5):1279-84. — View Citation

Moritz ML, Ayus JC. Prevention of hospital-acquired hyponatremia: a case for using isotonic saline. Pediatrics. 2003 Feb;111(2):227-30. Review. — View Citation

Neville KA, Verge CF, Rosenberg AR, O'Meara MW, Walker JL. Isotonic is better than hypotonic saline for intravenous rehydration of children with gastroenteritis: a prospective randomised study. Arch Dis Child. 2006 Mar;91(3):226-32. Epub 2005 Dec 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of change in serum sodium		8 to 20 hours
Secondary	hypertension		8 to 20 hours
Secondary	congestive heart failure		8 to 20 hours