Reexamining Hypotonic Intravenous Fluid Use

Withdrawn before enrolling · Not applicable

Conditions studied: Hyponatremia

In brief

The study aim is to isolate a single type of patient (pediatric patient with acute gastrointestinal symptoms) and evaluate the use of hypotonic (0.45 NS) vs. isotonic (0.9 NS) fluids in these patients in regards to changes in their serum sodium and iatrogenic hyponatremia.

Key facts

Study ID

NCT02667977

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

0

Starts

2014-10-01

Expected to finish

2016-06-01

Last updated by the study team

2016-01-29

Who can join

Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children 6 months to 16 years of age
• Symptoms of acute gastroenteritis (acute vomiting and/or diarrhea; symptoms of the "stomach flu")
• Admission to the hospital
• Requiring maintenance IVF as determined by the inpatient attending clinical judgment.

You may not qualify if…

• Age <6 months or age >16 years
• Weight >60 kg
• Admission to the PICU
• Chronic kidney disease
• Endocrine disorders
• Liver or heart disease
• Malignancies
• Human immunodeficiency virus
• Cystic fibrosis
• Epilepsy
• Guillan Barre Syndrome
• Multiple sclerosis.
• Any diuretic medications or medication known to affect ADH secretion
• Abnormal baseline sodium concentration (<133 mEq/L or > 147 mEq/L)
• Abnormal baseline systolic blood pressure (>95% based on age and height normative values)
• Hypotonic or isotonic fluids is deemed contraindicated
• Receives any additional intravenous fluids (NS or lactated ringer boluses) after study fluids have been initiated
• Taking a full diet at the time of admission
• Parents or legal guardians cannot be reached for consent
• Parents and children do not speak English or Spanish as their primary language
• High volume diarrhea (>3 loose stools per day) for a >1 week duration

Where it is running

• Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.