Status:

COMPLETED

Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

Lead Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Conditions:

Gastroenteritis

Bronchiolitis

Eligibility:

All Genders

1-18 years

Phase:

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2008

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT00457873

Start Date

January 1 2007

End Date

April 1 2008

Last Update

April 12 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Montreal Children's Hospital

Montreal, Quebec, Canada, H3H 1P3