Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water

Study Overview
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Brief Summary
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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
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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.

Official Title
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Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water, Randomized Clinical Trial

Conditions
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Hypernatremia

Intervention / Treatment
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* Drug: Hypotonic Solution
* Drug: Water Purified


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open Label randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous hypotonic solution<br>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. | Drug: Hypotonic Solution<br>* 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.<br>|
| Placebo Comparator: Enteral water<br>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. | Drug: Water Purified<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water. | Correction of hypernatremia is <145mEq/L serum sodium | every 12 hours during the first 48hrs of treatment and then every 24 hours for the first 5 days of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | the first 5 days of the study | 
| renal function | serum creatinine | the first 5 days of the study | 
| volume overload | volume overload determined by accumulated water balance in milliliters | the first 5 days of the study | 
| neurological alterations | neurological disorders defined as the presence of altered state of consciousness, seizures and/or cerebral edema | the first 5 days of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypernatremia, intravenous hypotonic solution, enteral water