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

• Status: Withdrawn
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University

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