Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema
Overview
- Phase
- Early Phase 1
- Intervention
- 3% Sodium Chloride
- Conditions
- Cerebral Edema
- Sponsor
- Stanford University
- Locations
- 1
- Primary Endpoint
- Total volume of intravenous hypertonic fluid administered to the patient
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
Investigators
Tim Angelotti
Associate Professor of Anesthesiology
Stanford University
Eligibility Criteria
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
Arms & Interventions
Standard Therapy
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.
Intervention: 3% Sodium Chloride
Balanced Therapy
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
Intervention: 23.4% Sodium Chloride
Balanced Therapy
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
Intervention: 8.4% Sodium Bicarbonate
Outcomes
Primary Outcomes
Total volume of intravenous hypertonic fluid administered to the patient
Time Frame: 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 Outcomes
- Urine output(Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment)