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0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children

Primary Purpose

Hyponatremia

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids

Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids

About this trial

This is an interventional treatment trial for Hyponatremia focused on measuring pediatrics, Hyponatremia, Sodium Chloride, maintenance fluids

Eligibility Criteria

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

Inclusion Criteria:

Aged 1 month to 18 years
Anticipated hospitalization >48 hours
Initial plasma Na between 135-145 mmol/L, with a management plan(determined by the responsible physician) to include IV fluids at > 80% of maintenance
For children who have had an IV saline bolus, it must have been completed three or more hours prior to having baseline bloods
Baseline bloods must be drawn within 3 hours of initial patient contact.

Exclusion Criteria:

Diagnosed with, or clinically suspected to have, any of the following: dehydration/gastroenteritis, heart or liver failure, portal hypertension with ascites, metabolic disease, SIADH, diabetes insipidus or mellitus, hypertension, adrenal insufficiency, renal failure [creatinine>100 μmol/L (<3 years); >150 μmol/L (> 3 years)], nephritic or nephrotic syndrome, Kawasaki disease, Sickle cell disease if requiring hyperhydration.
Clinically edematous
On diuretic medications
Plasma glucose is >15 mmol/L
Require CCU admission
Any patients requiring IV maintenance therapy having conditions/diseases not listed as excluded are eligible to be in this study

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Subjects in this arm will receive hypotonic (0.45% NaCl/5% dextrose) intravenous (IV) maintenance fluids.

Subjects in this arm will receive isotonic (0.9% NaCl/5% dextrose) intravenous (IV) maintenance fluids.

Outcomes

Primary Outcome Measures

Plasma urea, creatinine, glucose and electrolyte levels

Secondary Outcome Measures

Oral fluid intake

Weight

Standardized clinical assessment of edema

Blood pressure

Full Information

NCT ID

NCT00632775

First Posted

March 3, 2008

Last Updated

August 23, 2013

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT00632775

Brief Title

0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children

Official Title

Randomized, Double Blind, Controlled Trial of 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of this study is to compare the mean serum sodium at 48 hours following the initiation of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in children requiring maintenance IV fluid administration.

Detailed Description

Hyponatremia, has become increasingly recognized as a cause of morbidity and mortality in hospitalized children. The main etiology of hyponatremia in these children has been attributed to the use of hypotonic maintenance IV fluids. The practice of providing IV solutions containing 20-30 mmol/L of Na is based on "physiological needs" proposed by Holliday and Segarin 1957, derived from studies of 61 adults and children. The presence of non-physiologic ADH secretion in the great majority of hospitalized children due to nausea, stress, pain, and surgical interventions, has confirmed that Holliday and Segar's recommendations are frequently inappropriately applied. To avoid the development of hyponatremia, it has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance IV solution. The routine use of an isotonic maintenance fluid solution has not yet been studied, and concerns exist regarding the potential for hypernatremia and salt and water overload. If isotonic solutions are to be recommended routinely, their overall safety, and specifically the occurrence of dysnatremias and volume overload, should be evaluated in a controlled prospective trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyponatremia

Keywords

pediatrics, Hyponatremia, Sodium Chloride, maintenance fluids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Subjects in this arm will receive hypotonic (0.45% NaCl/5% dextrose) intravenous (IV) maintenance fluids.

Arm Title

Arm Type

Active Comparator

Arm Description

Subjects in this arm will receive isotonic (0.9% NaCl/5% dextrose) intravenous (IV) maintenance fluids.

Intervention Type

Drug

Intervention Name(s)

Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids

Other Intervention Name(s)

0.45% Sodium Chloride/5% dextrose

Intervention Description

Total daily fluid infusion equal to: 100 mls/kg/day for children weighing <10kg, 1000 mls + 50mls/kg for those weighing 10 to 20 kg, and 1500 mls +20 mls/kg for those >20kg.

Intervention Type

Drug

Intervention Name(s)

Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids

Other Intervention Name(s)

0.9% Sodium Chloride/5% Dextrose

Intervention Description

Total daily fluid infusion equal to: 100 mls/kg/day for children weighing <10kg, 1000 mls + 50mls/kg for those weighing 10 to 20 kg, and 1500 mls +20 mls/kg for those >20kg.

Primary Outcome Measure Information:

Title

Plasma urea, creatinine, glucose and electrolyte levels

Time Frame

At the time of IV start and every 24 hours thereafter

Secondary Outcome Measure Information:

Title

Oral fluid intake

Time Frame

The duration of the patient's participation in the study

Title

Weight

Time Frame

Every 24 hours

Title

Standardized clinical assessment of edema

Time Frame

Every 24 hours

Title

Blood pressure

Time Frame

Every morning

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 1 month to 18 years Anticipated hospitalization >48 hours Initial plasma Na between 135-145 mmol/L, with a management plan(determined by the responsible physician) to include IV fluids at > 80% of maintenance For children who have had an IV saline bolus, it must have been completed three or more hours prior to having baseline bloods Baseline bloods must be drawn within 3 hours of initial patient contact. Exclusion Criteria: Diagnosed with, or clinically suspected to have, any of the following: dehydration/gastroenteritis, heart or liver failure, portal hypertension with ascites, metabolic disease, SIADH, diabetes insipidus or mellitus, hypertension, adrenal insufficiency, renal failure [creatinine>100 μmol/L (<3 years); >150 μmol/L (> 3 years)], nephritic or nephrotic syndrome, Kawasaki disease, Sickle cell disease if requiring hyperhydration. Clinically edematous On diuretic medications Plasma glucose is >15 mmol/L Require CCU admission Any patients requiring IV maintenance therapy having conditions/diseases not listed as excluded are eligible to be in this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Denis Geary, MD

Organizational Affiliation

The Hospital for Sick Children, Toronto Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25751673

Citation

Friedman JN, Beck CE, DeGroot J, Geary DF, Sklansky DJ, Freedman SB. Comparison of isotonic and hypotonic intravenous maintenance fluids: a randomized clinical trial. JAMA Pediatr. 2015 May;169(5):445-51. doi: 10.1001/jamapediatrics.2014.3809.

Results Reference

derived

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0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children

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