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Maintenance Intravenous Fluids in Children

Primary Purpose

Hyponatremia

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Isotonic fluid
Hypotonic fluid
Hypotonic fluid
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyponatremia focused on measuring maintenance fluids, hyponatremia, vasopressin, children

Eligibility Criteria

3 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All children (3 months to 12 years) who are admitted to pediatric ward or pediatric ICU, who require exclusive intravenous maintenance fluid therapy for at least 24 hours will be eligible for the study

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.
  • Abnormal serum sodium or Hyperglycemia at Presentation:

    • Hyponatremia : serum sodium < 130 mmol/L.
    • Hypernatremia : serum sodium >150 mmol/L.
    • Hyperglycemia: blood glucose > 180 mg/ dl.
  • 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.
  • Child who is receiving drugs which cause abnormality in serum sodium such as diuretics, vasopressin, etc.

Sites / Locations

  • All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Isotonic fluid group

Fluid restriction group

Hypotonic fluid group

Arm Description

Normal saline in 5% dextrose at standard maintenance rate

Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose

N/5 saline in 5% dextrose at standard maintenance rate

Outcomes

Primary Outcome Measures

Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L)

Secondary Outcome Measures

Incidence of Hypernatremia (Serum Sodium >150 mmol/L)
Incidence of Symptomatic Hyponatremia
Defined as Hyponatremia (serum sodium < 130 mnol/L)and presence of symptoms attributed to hyponatremia such as altered sensorium, seizure, headache, and vomiting which can not be explained otherwise.
Incidence of Symptomatic Hypernatremia
Symptomatic hypernatremia is defined as serum sodium > 150 mmol/L and the presence of symptoms like altered sensorium, seizure, headache and vomiting not explained otherwise.

Full Information

First Posted
February 12, 2008
Last Updated
August 8, 2011
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT00621348
Brief Title
Maintenance Intravenous Fluids in Children
Official Title
A RCT to Evaluate the Effect of Normal Saline in 5% Dextrose at Maintenance Rate, N/5 Saline in 5% Dextrose at 2/3 Maintenance Rate and N/5 Saline in 5% Dextrose at Maintenance Rate on Incidence of Hyponatremia in Hospitalized Children.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized children. Hypothesis: Use of normal saline in 5% dextrose or reduced (2/3) volume of N/5 saline in 5% dextrose reduces incidence of hyponatremia (serum sodium 130 mmol/L) by two-thirds when compared to N/5 saline in 5% dextrose at standard maintenance rate in hospitalized children receiving intravenous maintenance fluids.
Detailed Description
Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized children. We therefore plan to conduct a randomized controlled trial to evaluate the effect of normal saline in 5% dextrose at standard maintenance rate, reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose and N/5 saline in 5% dextrose at standard maintenance rate on the incidence of hyponatremia in hospitalized children, aged 3 months- 12 years. To determine serial plasma vasopressin levels in hospitalized children at baseline, 24 hours and 48 hours of intravenous fluid therapy and compare the values in the three fluid regimens. Study design: Randomized controlled trial. 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 for estimation of serum sodium, potassium, chloride, bicarbonate, blood gas, blood sugar, blood urea, serum creatinine, and plasma osmolality. A sample for estimation of plasma vasopressin will be collected at baseline. After randomization into three groups, one group of children will receive N/5 saline in 5% dextrose 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 of children will receive N/5 saline in 5% dextrose at 2/3 maintenance rate. The third group will receive dextrose normal saline at standard maintenance rate. Serum Na+, K+ and urine Na+, K+ will be estimated every 12 hourly till the patient is on intravenous fluid therapy and 12 hrs after stopping exclusive intravenous maintenance fluids. Serum and urine osmolality will be estimated every 24 hrs by an osmometer. Plasma vasopressin will be estimated in children in the 3 groups at 24, and 48 hours of intravenous fluid therapy. Children will be weighed every 24 hours. The fluid balance, sodium balance, free water clearance will be calculated in a subset of children. The study measurements will be carried out only till the time the child is on exclusive intravenous maintenance fluid therapy or 72 hrs of starting the intravenous fluid therapy. The decision to decrease/ stop intravenous fluid therapy will be left to the treating unit. The primary outcome measure will be incidence of hyponatremia (defined as serum Na+ less than 130 mmol/L). The secondary outcomes studied will be Plasma vasopressin levels at 24 hr and 48 hours and incidence of hypernatremia. Sample size: Based on literature review, the incidence of hyponatremia with standard intravenous fluid therapy is approximately 30%. Sample of 72 patients will be needed in each group to demonstrate the decrease in incidence of hyponatremia to 10%, with a beta of 0.2 (Power 80%) and alpha error of 0.05. Analysis: The data will be analyzed using STATA software. The outcomes (primary and secondary) in the 3 groups will be compared. For continuous variables, t test or Wilcoxon rank-sum test will be used to determine statistical significance. For categorical variables, chi square test will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia
Keywords
maintenance fluids, hyponatremia, vasopressin, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isotonic fluid group
Arm Type
Active Comparator
Arm Description
Normal saline in 5% dextrose at standard maintenance rate
Arm Title
Fluid restriction group
Arm Type
Active Comparator
Arm Description
Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
Arm Title
Hypotonic fluid group
Arm Type
Active Comparator
Arm Description
N/5 saline in 5% dextrose at standard maintenance rate
Intervention Type
Drug
Intervention Name(s)
Isotonic fluid
Other Intervention Name(s)
Dextrose normal saline
Intervention Description
0.9% saline with 5% dextrose at standard maintenance rate
Intervention Type
Drug
Intervention Name(s)
Hypotonic fluid
Other Intervention Name(s)
Hypotonic fluid,, 0.2 % saline in 5 % dextrose
Intervention Description
Reduced volume (two thirds of standard maintenance rate) of N/5 saline in 5% dextrose
Intervention Type
Drug
Intervention Name(s)
Hypotonic fluid
Other Intervention Name(s)
0.2 % saline in 5% dextrose
Intervention Description
N/5 saline in 5% dextrose at standard maintenance rate
Primary Outcome Measure Information:
Title
Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L)
Time Frame
72 hrs
Secondary Outcome Measure Information:
Title
Incidence of Hypernatremia (Serum Sodium >150 mmol/L)
Time Frame
72 hrs
Title
Incidence of Symptomatic Hyponatremia
Description
Defined as Hyponatremia (serum sodium < 130 mnol/L)and presence of symptoms attributed to hyponatremia such as altered sensorium, seizure, headache, and vomiting which can not be explained otherwise.
Time Frame
72 hrs
Title
Incidence of Symptomatic Hypernatremia
Description
Symptomatic hypernatremia is defined as serum sodium > 150 mmol/L and the presence of symptoms like altered sensorium, seizure, headache and vomiting not explained otherwise.
Time Frame
72 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All children (3 months to 12 years) who are admitted to pediatric ward or pediatric ICU, who require exclusive intravenous maintenance fluid therapy for at least 24 hours will be eligible for the study 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. Abnormal serum sodium or Hyperglycemia at Presentation: Hyponatremia : serum sodium < 130 mmol/L. Hypernatremia : serum sodium >150 mmol/L. Hyperglycemia: blood glucose > 180 mg/ dl. 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. Child who is receiving drugs which cause abnormality in serum sodium such as diuretics, vasopressin, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Lodha, MD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
20668885
Citation
Kannan L, Lodha R, Vivekanandhan S, Bagga A, Kabra SK, Kabra M. Intravenous fluid regimen and hyponatraemia among children: a randomized controlled trial. Pediatr Nephrol. 2010 Nov;25(11):2303-9. doi: 10.1007/s00467-010-1600-4. Epub 2010 Jul 29.
Results Reference
result

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Maintenance Intravenous Fluids in Children

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