Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water

Hospital Civil de Guadalajara

Status: Not yet enrolling

Conditions: Hypernatremia

Treatments: Drug: Water Purified; Drug: Hypotonic Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06061783

Correction of hypernatremia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups, including a placebo group

Intravenous hypotonic solution

Active Comparator group

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.

Treatment:

Drug: Hypotonic Solution

Enteral water

Placebo Comparator group

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.

Treatment:

Drug: Water Purified