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Clinical trial

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

ID
Name
Correction of hypernatremia
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. 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.
Trial arms
Trial start
2023-11-30
Estimated PCD
2024-09-30
Trial end
2024-09-30
Status
Not yet recruiting
Treatment
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.
Arms:
Intravenous hypotonic solution
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.
Arms:
Enteral water
Size
178
Primary endpoint
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.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open Label randomized trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 178, 'type': 'ESTIMATED'}}
Updated at
2023-09-29

1 organization

2 products

1 indication

Organization
Hospital Civil de Guadalajara
Product
Hypotonic Solution
Indication
Sodium imbalance
Product
Water Purified