Reexamining Hypotonic Intravenous Fluid Use

NCT02667977 | Withdrawn

• 1 other identifier: 2014-15901
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyponatremia

Keywords

fluids, pediatric, gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Change in sodium

  8 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

These patients will receive Dextrose 5% and 0.9 NS in their maintenance IV fluids

Other: 0.9 Normal Saline

Group 2

ACTIVE COMPARATOR

These patients will receive Dextrose 5% and 0.45 NS in their maintenance IV fluids

Other: 0.45 Normal Saline

Interventions

0.9 Normal Saline OTHER

Use of 0.9 Normal Saline for maintenance IV fluids

Group 1

0.45 Normal Saline OTHER

Use of 0.45 Normal Saline for maintenance IV fluids

Group 2

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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)

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Hyponatremia; Gastroenteritis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Waheeda Samady, MD

  Lurie Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Hospitalist

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: January 29, 2016
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)