NCT06061783

Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Hospital Civil de Guadalajara · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypernatremia

Interventions

Type	Name	Description
DRUG	Hypotonic Solution	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.
DRUG	Water Purified	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.

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2023-09-29
• Last updated: 2023-09-29