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Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

Primary Purpose

Gastroenteritis, Bronchiolitis, Sepsis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
0.9% saline in 5% dextrose (intravenous)
0.45% saline in 5% dextrose (intravenous)
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteritis focused on measuring surgery

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Montreal Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

0.9% saline in 5% dextrose (intravenous)

0.45% saline in 5% dextrose (intravenous)

Outcomes

Primary Outcome Measures

rate of change in serum sodium

Secondary Outcome Measures

hypertension
congestive heart failure

Full Information

First Posted
April 5, 2007
Last Updated
April 4, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00457873
Brief Title
Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy
Official Title
Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis, Bronchiolitis, Sepsis, Urinary Tract Infection
Keywords
surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
0.9% saline in 5% dextrose (intravenous)
Arm Title
B
Arm Type
Active Comparator
Arm Description
0.45% saline in 5% dextrose (intravenous)
Intervention Type
Drug
Intervention Name(s)
0.9% saline in 5% dextrose (intravenous)
Other Intervention Name(s)
isotonic saline
Intervention Type
Drug
Intervention Name(s)
0.45% saline in 5% dextrose (intravenous)
Primary Outcome Measure Information:
Title
rate of change in serum sodium
Time Frame
8 to 20 hours
Secondary Outcome Measure Information:
Title
hypertension
Time Frame
8 to 20 hours
Title
congestive heart failure
Time Frame
8 to 20 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany J Foster, MD, MSCE
Organizational Affiliation
Montreal Children's Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15121942
Citation
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. doi: 10.1542/peds.113.5.1279.
Results Reference
result
PubMed Identifier
12563043
Citation
Moritz ML, Ayus JC. Prevention of hospital-acquired hyponatremia: a case for using isotonic saline. Pediatrics. 2003 Feb;111(2):227-30. doi: 10.1542/peds.111.2.227.
Results Reference
result
PubMed Identifier
16352625
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. doi: 10.1136/adc.2005.084103. Epub 2005 Dec 13.
Results Reference
result
PubMed Identifier
21943218
Citation
Saba TG, Fairbairn J, Houghton F, Laforte D, Foster BJ. A randomized controlled trial of isotonic versus hypotonic maintenance intravenous fluids in hospitalized children. BMC Pediatr. 2011 Sep 23;11:82. doi: 10.1186/1471-2431-11-82.
Results Reference
derived

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Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

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