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Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children (surgical-Na)

Primary Purpose

Hyponatremia

Status
Completed
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
0.45% NaCl/dextrose 5%
0.3% NaCl/dextrose 5%
Sponsored by
Hospital General de Niños Pedro de Elizalde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyponatremia focused on measuring Hyponatremia, Water-Electrolyte Imbalance

Eligibility Criteria

1 Month - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Postsurgical children admitted to HGNPE Department of Surgery between january 2010 and october 2011.

Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid administration is anticipated to be intravenous, in the first 12 hours following surgery.

Informed consent of parent/guardian.

Exclusion Criteria:

  • • Children with illness that have primary fluid and electrolyte imbalance such as:

    • Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia (<35oC), tachycardia, prolonged capillary filling time (>3 seconds), hypotension (BP < 5th percentile for age), oliguria (<0.5 ml/kg/hr), hypoxemia, hyperlactatemia, requirement of fluid bolus and/ or vasopressors.
    • Diarrhea and Dehydration: Children presenting with diarrhea and features of dehydration: lethargy, irritability and altered sensorium, thirst, decreased urine output, sunken eyes & dry mucous membranes, loss of skin elasticity.; children with ongoing diarrhea will be excluded even if there is no dehydration.

    • Fluid Overload: Cirrhosis, Congestive heart failure, Acute and Chronic renal failure, Nephrotic syndrome.

      • Hyperglycemia: blood glucose > 180 mg/ dl.
      • Require ICU admission.
      • Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification.
      • Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
      • Patients with known pre-existing risk of PNa derangements: DI or SIADH

Sites / Locations

  • Hospital de Niños Pedro de Elizalde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

half saline

third saline

Arm Description

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

Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids.

Outcomes

Primary Outcome Measures

Change in Sodium Levels

Secondary Outcome Measures

IV Fluid Intake

Full Information

First Posted
November 30, 2010
Last Updated
January 17, 2017
Sponsor
Hospital General de Niños Pedro de Elizalde
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1. Study Identification

Unique Protocol Identification Number
NCT01251770
Brief Title
Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
Acronym
surgical-Na
Official Title
Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General de Niños Pedro de Elizalde

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.
Detailed Description
Background: Despite prescription of maintenance IV fluids in hospitalized children is widely used since 1957 (Holiday & Segar), it is not always adequate for children with acute diseases, leading to hyponatremia. This mainly occurs due to a non-physiologic ADH secretion in this group of patients due to nausea, stress, pain, and surgical interventions, and the use of hypotonic maintenance IV fluids. 0.3% NaCl/dextrose 5%, is widely use as IV maintenance fluid in children after surgery. There is evidence suggesting that these IV fluids used in postsurgical hospitalized patients do not provide the adequate amount of sodium they require, leading to an increased risk of developing hyponatremia. Using 0.45% NaCl/dextrose 5% as IV maintenance fluid in these children would prevent hyponatremia, but this treatment has not been totally studied yet. Study procedures: Hospitalized children who fulfill inclusion criteria and not having any of the exclusion criteria will be considered for the enrolment after written informed consent. Venous blood samples will be taken at enrollment (baseline) for estimation of serum sodium. After randomization, one group will receive 0.3% NaCl/dextrose 5%, IV, at standard maintenance rate (100 ml/kg for the first 10 kg of body weight, 50 ml/kg for the next 10 kg, and 20 ml/kg for body weight exceeding 20 kg). The second group will receive 0.45% NaCl/dextrose 5%, IV, at the same rate. Serum sodium will be estimated in both groups after 12 hours of intravenous fluid therapy. Children who required oral fluids will be excluded from per-protocol analysis, and only analyzed for intention to treat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia
Keywords
Hyponatremia, Water-Electrolyte Imbalance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
half saline
Arm Type
Experimental
Arm Description
Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.
Arm Title
third saline
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids.
Intervention Type
Drug
Intervention Name(s)
0.45% NaCl/dextrose 5%
Other Intervention Name(s)
half saline
Intervention Description
Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 body surface.
Intervention Type
Drug
Intervention Name(s)
0.3% NaCl/dextrose 5%
Other Intervention Name(s)
third saline
Intervention Description
Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 surface.
Primary Outcome Measure Information:
Title
Change in Sodium Levels
Time Frame
Change from baseline in sodium level after 12 hours
Secondary Outcome Measure Information:
Title
IV Fluid Intake
Time Frame
12 hours from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postsurgical children admitted to HGNPE Department of Surgery between january 2010 and october 2011. Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid administration is anticipated to be intravenous, in the first 12 hours following surgery. Informed consent of parent/guardian. Exclusion Criteria: • Children with illness that have primary fluid and electrolyte imbalance such as: Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia (<35oC), tachycardia, prolonged capillary filling time (>3 seconds), hypotension (BP < 5th percentile for age), oliguria (<0.5 ml/kg/hr), hypoxemia, hyperlactatemia, requirement of fluid bolus and/ or vasopressors. Diarrhea and Dehydration: Children presenting with diarrhea and features of dehydration: lethargy, irritability and altered sensorium, thirst, decreased urine output, sunken eyes & dry mucous membranes, loss of skin elasticity.; children with ongoing diarrhea will be excluded even if there is no dehydration. Fluid Overload: Cirrhosis, Congestive heart failure, Acute and Chronic renal failure, Nephrotic syndrome. Hyperglycemia: blood glucose > 180 mg/ dl. Require ICU admission. Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification. Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure. Patients with known pre-existing risk of PNa derangements: DI or SIADH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuela Dicembrino, md
Organizational Affiliation
Hospital de Niños Pedro de Elizalde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Niños Pedro de Elizalde
City
Buenos Aires
State/Province
CF
ZIP/Postal Code
C1270AAN
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
16754657
Citation
Choong K, Kho ME, Menon K, Bohn D. Hypotonic versus isotonic saline in hospitalised children: a systematic review. Arch Dis Child. 2006 Oct;91(10):828-35. doi: 10.1136/adc.2005.088690. Epub 2006 Jun 5.
Results Reference
background
PubMed Identifier
19818450
Citation
Neville KA, Sandeman DJ, Rubinstein A, Henry GM, McGlynn M, Walker JL. Prevention of hyponatremia during maintenance intravenous fluid administration: a prospective randomized study of fluid type versus fluid rate. J Pediatr. 2010 Feb;156(2):313-9.e1-2. doi: 10.1016/j.jpeds.2009.07.059. Epub 2009 Oct 9.
Results Reference
background
PubMed Identifier
18036144
Citation
Yung M, Keeley S. Randomised controlled trial of intravenous maintenance fluids. J Paediatr Child Health. 2009 Jan-Feb;45(1-2):9-14. doi: 10.1111/j.1440-1754.2007.01254.x. Epub 2007 Nov 25.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/17981159
Description
Hyponatremia treatment guidelines 2007: expert panel recommendations

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Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children

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