Cerebral Edema, Saline Solution, Hypertonic
Conditions
Brief summary
Many patients with traumatic brain injuries (including strokes, blood clots, or other brain injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat brain swelling (cerebral edema). Current therapies consist of a mixture of sodium and chloride, which can lead to high levels of serum chloride and increased total body water. High levels of chloride can cause acidosis, which can cause the body to function sub-optimally. Therefore, the investigators are proposing to use two concentrated solutions in these patients at the same time that will allow for a lower total volume of solution administration and reduce the rise in chloride to prevent acidosis. The main outcome will therefore be the patients sodium level, chloride level and serum pH.
Interventions
3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
DRUG23.4% Sodium Chloride
23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
DRUG8.4% Sodium Bicarbonate
8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to consent * 18 years or older * English speaking * Clinical indication (intracranial hypertension from cerebral edema) for hypertonic fluid administration
Exclusion criteria
* Fails to consent * \< 18 years old * Hypertonic therapy not indicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total volume of intravenous hypertonic fluid administered to the patient | The fluid will be infused until the new serum sodium goal is achieved. This outcome measure will be assessed 1 week after study enrollment | Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine output | Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment | Urine output will be collected and measured quantitatively in milliliter units. |
Countries
United States
Outcome results
None listed