Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema

Conditions
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Cerebral Edema, Saline Solution, Hypertonic

Intervention / Treatment
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* Drug: 3% Sodium Chloride
* Drug: 23.4% Sodium Chloride
* Drug: 8.4% Sodium Bicarbonate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Therapy<br>This group will receive 3% hypertonic sodium chloride for the management of their cerebral edema. 3% Sodium Chloride is the generic name of this intravenous fluid preparation. | Drug: 3% Sodium Chloride<br>* 3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure<br>|
| Experimental: Balanced Therapy<br>This group will undergo two simultaneous infusions. 23.4% sodium chloride and 8.4% sodium bicarbonate will be infused at the same time in various ratios for management of cerebral edema with a balanced approach | Drug: 23.4% Sodium Chloride<br>* 23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure<br>Drug: 8.4% Sodium Bicarbonate<br>* 8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of intravenous hypertonic fluid administered to the patient | Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid. | The fluid will be infused until the new serum sodium goal is achieved. This outcome measure will be assessed 1 week after study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine output | Urine output will be collected and measured quantitatively in milliliter units. | Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment |