Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water

Not Applicable

Not yet recruiting

• Conditions: Hypernatremia
• Interventions: Drug: Hypotonic Solution; Drug: Water Purified

• Registration Number: NCT06061783
• Lead Sponsor: Hospital Civil de Guadalajara

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-25
• Last Update Submitted: 2023-09-25
• Study First Posted: 2023-09-29
• Last Update Posted: 2023-09-29
• Study Start: 2023-11-30
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• Hospitalized patients with hypernatremia (serum sodium>145mEq/L).

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Exclusion Criteria

• Age below 18 years
• Pregnant, on dialysis
• Unwilling to participate or without informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous hypotonic solution	Hypotonic Solution	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.
Enteral water	Water Purified	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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