Overview

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

Status:
Withdrawn
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Stanford University