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Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water

Primary Purpose

Hypernatremia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypotonic Solution
Water Purified
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypernatremia focused on measuring Hypernatremia, intravenous hypotonic solution, enteral water

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hospitalized patients with hypernatremia (serum sodium>145mEq/L). Exclusion Criteria: Age below 18 years Pregnant, on dialysis Unwilling to participate or without informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Intravenous hypotonic solution

    Enteral water

    Arm Description

    In this group, the administration will be according to the presence of basal hyperglycemia on the day before the assignment (>180mg/dL). If hyperglycemia is present, it will be glucose solution 5% 500ml + injectable water 500ml intravenous every 8 hours for a total of 3,600ml daily. If there is no hyperglycemia, it will be 5% glucose solution 1,200ml every 8 hours for a total of 3,600ml per day.

    This group will receive bottled water through the nasogastric or orogastric tube at a dose of 150 ml/hour for a total of 3,600 ml per day.

    Outcomes

    Primary Outcome Measures

    The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water.
    Correction of hypernatremia is <145mEq/L serum sodium

    Secondary Outcome Measures

    mortality
    renal function
    serum creatinine
    volume overload
    volume overload determined by accumulated water balance in milliliters
    neurological alterations
    neurological disorders defined as the presence of altered state of consciousness, seizures and/or cerebral edema

    Full Information

    First Posted
    September 20, 2023
    Last Updated
    September 25, 2023
    Sponsor
    Hospital Civil de Guadalajara
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06061783
    Brief Title
    Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water
    Official Title
    Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water, Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 30, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    September 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Civil de Guadalajara

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units. In this study, the investigator aims, for the first time, to compare two strategies used for the correction of hypernatremia, using intravenous hypotonic solution compared to naso- or orogastric tube enteral water.
    Detailed Description
    Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units, increasing mortality. Currently, the most effective correction strategy for hypernatremia (intravenous hypotonic solution compared to enteral water) is still a matter of debate due to a lack of evidence and clinical trials. This study aims to determine whether the administration of intravenous hypotonic solution is more effective in the correction of hypernatremia compared to enteral water by naso- or orogastric tube. Therefore, the investigator proposes the first randomized clinical trial, which compares two strategies used for the correction of hypernatremia, with this we will determine which of the two is more effective, and we will also compare the speed of correction, renal function during hospitalization with serum creatinine and we will evaluate its safety.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypernatremia
    Keywords
    Hypernatremia, intravenous hypotonic solution, enteral water

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Open Label randomized trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    178 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravenous hypotonic solution
    Arm Type
    Active Comparator
    Arm Description
    In this group, the administration will be according to the presence of basal hyperglycemia on the day before the assignment (>180mg/dL). If hyperglycemia is present, it will be glucose solution 5% 500ml + injectable water 500ml intravenous every 8 hours for a total of 3,600ml daily. If there is no hyperglycemia, it will be 5% glucose solution 1,200ml every 8 hours for a total of 3,600ml per day.
    Arm Title
    Enteral water
    Arm Type
    Placebo Comparator
    Arm Description
    This group will receive bottled water through the nasogastric or orogastric tube at a dose of 150 ml/hour for a total of 3,600 ml per day.
    Intervention Type
    Drug
    Intervention Name(s)
    Hypotonic Solution
    Intervention Description
    Intravenous administration of 5% glucose solution 1,200ml every 8 hours for a total of 3,600ml per day. If hyperglycemia is present, it will be glucose solution 5% 500ml + injectable water 500ml intravenous every 8 hours for a total of 3,600ml daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Water Purified
    Intervention Description
    administration of bottled water through the nasogastric or orogastric tube at a dose of 150 ml/hour for a total of 3,600 ml per day.
    Primary Outcome Measure Information:
    Title
    The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water.
    Description
    Correction of hypernatremia is <145mEq/L serum sodium
    Time Frame
    every 12 hours during the first 48hrs of treatment and then every 24 hours for the first 5 days of the study.
    Secondary Outcome Measure Information:
    Title
    mortality
    Time Frame
    the first 5 days of the study
    Title
    renal function
    Description
    serum creatinine
    Time Frame
    the first 5 days of the study
    Title
    volume overload
    Description
    volume overload determined by accumulated water balance in milliliters
    Time Frame
    the first 5 days of the study
    Title
    neurological alterations
    Description
    neurological disorders defined as the presence of altered state of consciousness, seizures and/or cerebral edema
    Time Frame
    the first 5 days of the study
    Other Pre-specified Outcome Measures:
    Title
    hyperglycemia, glucose >180mg/dL
    Description
    hyperglycemia defined as capillary glucose >180mg/dL
    Time Frame
    the first 5 days of the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hospitalized patients with hypernatremia (serum sodium>145mEq/L). Exclusion Criteria: Age below 18 years Pregnant, on dialysis Unwilling to participate or without informed consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan Samuel Chavez Iñiguez
    Phone
    3313299609
    Email
    jonarchi_10@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan Samuel Chavez Iñiguez
    Organizational Affiliation
    HCG
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water

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