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Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia

Primary Purpose

Hyponatremia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
0.3% Saline in 3.3% dextrose
0.45% Saline in 5% dextrose
0.9% Saline in 5% dextrose
Sponsored by
Instituto Tecnologico y de Estudios Superiores de Monterey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyponatremia

Eligibility Criteria

3 Months - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children between 3 months to 15 years.
  • Need for intravenous fluids for 8 hours or more.
  • Normal serum sodium at the beginning of the study of the study (135-145 mEQ/L).
  • Acute respiratory problems (acute asthma attack, bronchiolitis or pneumonia).
  • Acute gastrointestinal disorders (viral o bacterial gastroenteritis).
  • Elective surgical procedures.
  • Pre, peri o post operative patients (acute appendicitis, intussusception, intestinal perforation, ileus).

Exclusion Criteria:

  • Severe hyponatremia (serum sodium < 125 mEq/L).
  • Severe hypernatremia (serum sodium >155 mEq/L).
  • Need for intravenous fluids for less than 8 hours according with their treating physician.
  • Severe dehydration or Shock.
  • Preexisting chronic diseases (renal diseases, heart diseases or endocrine disorders).
  • Neurologic diseases.
  • Head trauma.
  • Cerebral edema or Intracranial hypertension.
  • Diabetic ketoacidosis.
  • Use of diuretics one week or less before the study.
  • Need for admission to the pediatric critical intensive care unit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group 1: 0.3% Saline in 3.3% dextrose (intravenous)

    Group 2: 0.45% Saline in 5% dextrose (intravenous)

    Group 3: 0.9% Saline in 5% dextrose (intravenous)

    Arm Description

    Group 1: 0.3% Saline in 3.3% dextrose (intravenous)

    Group 2: 0.45% Saline in 5% dextrose (intravenous)

    Group 3: 0.9% Saline in 5% dextrose (intravenous)

    Outcomes

    Primary Outcome Measures

    Hospital Acquired Hyponatremia
    Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study

    Secondary Outcome Measures

    Dysnatraemias at T8
    hyponatraemia (defined as serum sodium < 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium > 145 mmol/L)
    Adverse Reactions Attributed to Acute Plasma Sodium Changes
    Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours

    Full Information

    First Posted
    July 14, 2013
    Last Updated
    October 21, 2016
    Sponsor
    Instituto Tecnologico y de Estudios Superiores de Monterey
    Collaborators
    Tecnologico de Monterrey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01909336
    Brief Title
    Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia
    Official Title
    Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Tecnologico y de Estudios Superiores de Monterey
    Collaborators
    Tecnologico de Monterrey

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.
    Detailed Description
    Multicenter, Randomized, Controlled clinical trial. The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions This study will include 150 patients in 2 groups according to these type of pathology: group 1: medical conditions which includes respiratory problems (pneumonia, bronchiolitis, acute asthma attack) and acute gastrointestinal problems (bacterial or viral gastroenteritis) and group 2: surgical conditions (pre, peri or postoperative patients will be included). Each group will be randomized to receive 3 types of interventions: 0.3% Saline (hypotonic solution), 0.45% Saline (hypotonic solution) or 0.9% Saline (isotonic solution). In non-dehydrated patients the daily total volume of liquid infused will be determined by the volumetric Holliday- Segar* formula and the daily total volume will be calculated by adding the maintenance requirements (using the Holliday Segar formula) to the fluid deficit (according to percent of estimated weight**) in dehydrated patients. The glucose concentrations in the first group will be 3.3%, and in group 2 and 3 will be 5%. The potassium concentration will be 20mEq/L in all groups. Blood samples will be collected before, 8 hours and 24 hours after the start of intravenous fluid, for the analysis of sodium, potassium, glucose, urea and creatinine. The adverse clinical outcomes at 8 and 24 hours of the start of intravenous fluid will also be recorded. The sodium plasma level, the incidence of hyponatremia and the adverse clinical outcomes will be compared. *0-10 kilogram (kg): 100ml/kg per day; 10-20 kg: 1000 ml + 50 ml/kg/day over 10 kg; >20 kg: 1500 ml + 20ml/ kg over 20kg ** In patients under 10 kg correspond to a loss of 5% (50 mL/kg) in mild dehydration and 10% in moderate dehydration. In 10 kg or more: 3% (30 mL/kg) in mild dehydration and 6% (60 mL/kg) in moderate dehydration.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    161 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1: 0.3% Saline in 3.3% dextrose (intravenous)
    Arm Type
    Active Comparator
    Arm Description
    Group 1: 0.3% Saline in 3.3% dextrose (intravenous)
    Arm Title
    Group 2: 0.45% Saline in 5% dextrose (intravenous)
    Arm Type
    Active Comparator
    Arm Description
    Group 2: 0.45% Saline in 5% dextrose (intravenous)
    Arm Title
    Group 3: 0.9% Saline in 5% dextrose (intravenous)
    Arm Type
    Active Comparator
    Arm Description
    Group 3: 0.9% Saline in 5% dextrose (intravenous)
    Intervention Type
    Drug
    Intervention Name(s)
    0.3% Saline in 3.3% dextrose
    Other Intervention Name(s)
    Hypotonic Solutions: 0.3% Saline + 3.3% dextrose
    Intervention Description
    Hypotonic Solutions: 0.3% Saline in 3.3% dextrose
    Intervention Type
    Drug
    Intervention Name(s)
    0.45% Saline in 5% dextrose
    Other Intervention Name(s)
    Hypotonic Solutions: 0.45% Saline in 5% dextrose
    Intervention Description
    Hypotonic Solutions: 0.45% Saline in 5% dextrose
    Intervention Type
    Drug
    Intervention Name(s)
    0.9% Saline in 5% dextrose
    Other Intervention Name(s)
    Isotonic Solutions 0.9% Saline in 5% dextrose
    Intervention Description
    Isotonic Solutions 0.9% Saline in 5% dextrose
    Primary Outcome Measure Information:
    Title
    Hospital Acquired Hyponatremia
    Description
    Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study
    Time Frame
    8 hours
    Secondary Outcome Measure Information:
    Title
    Dysnatraemias at T8
    Description
    hyponatraemia (defined as serum sodium < 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium > 145 mmol/L)
    Time Frame
    8 hours
    Title
    Adverse Reactions Attributed to Acute Plasma Sodium Changes
    Description
    Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours
    Time Frame
    8 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children between 3 months to 15 years. Need for intravenous fluids for 8 hours or more. Normal serum sodium at the beginning of the study of the study (135-145 mEQ/L). Acute respiratory problems (acute asthma attack, bronchiolitis or pneumonia). Acute gastrointestinal disorders (viral o bacterial gastroenteritis). Elective surgical procedures. Pre, peri o post operative patients (acute appendicitis, intussusception, intestinal perforation, ileus). Exclusion Criteria: Severe hyponatremia (serum sodium < 125 mEq/L). Severe hypernatremia (serum sodium >155 mEq/L). Need for intravenous fluids for less than 8 hours according with their treating physician. Severe dehydration or Shock. Preexisting chronic diseases (renal diseases, heart diseases or endocrine disorders). Neurologic diseases. Head trauma. Cerebral edema or Intracranial hypertension. Diabetic ketoacidosis. Use of diuretics one week or less before the study. Need for admission to the pediatric critical intensive care unit
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claudia Montserrat Flores Robles, MD
    Organizational Affiliation
    Tecnologico de Monterrey
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Carlos Alberto Cuello García, MD
    Organizational Affiliation
    Centro de Medicina Basada en Evidencias, Escuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17592470
    Citation
    Moritz ML, Ayus JC. Hospital-acquired hyponatremia--why are hypotonic parenteral fluids still being used? Nat Clin Pract Nephrol. 2007 Jul;3(7):374-82. doi: 10.1038/ncpneph0526.
    Results Reference
    background
    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
    18838929
    Citation
    Montanana PA, Modesto i Alapont V, Ocon AP, Lopez PO, Lopez Prats JL, Toledo Parreno JD. The use of isotonic fluid as maintenance therapy prevents iatrogenic hyponatremia in pediatrics: a randomized, controlled open study. Pediatr Crit Care Med. 2008 Nov;9(6):589-97. doi: 10.1097/PCC.0b013e31818d3192.
    Results Reference
    background

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    Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia

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