Hypernatremia
Conditions
Keywords
Hypernatremia, intravenous hypotonic solution, enteral water
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.
Interventions
DRUGHypotonic 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.
DRUGWater 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.
Sponsors
Hospital Civil de Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| mortality | the first 5 days of the study | — |
| renal function | the first 5 days of the study | serum creatinine |
| volume overload | the first 5 days of the study | volume overload determined by accumulated water balance in milliliters |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| hyperglycemia, glucose >180mg/dL | the first 5 days of the study | hyperglycemia defined as capillary glucose \>180mg/dL |
Contacts
Primary ContactJonathan Samuel Chavez Iñiguez
Outcome results
None listed