Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation
Withdrawn before enrolling · Early Phase 1
Conditions studied: Cerebral Edema, Saline Solution, Hypertonic
In brief
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.
Key facts
- Study ID
- NCT03330704
- Run by
- Stanford University
- People needed
- 0
- Starts
- 2017-11-28
- Expected to finish
- 2020-01-01
- Last updated by the study team
- 2020-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able to consent
- 18 years or older
- English speaking
- Clinical indication (intracranial hypertension from cerebral edema) for hypertonic fluid administration
You may not qualify if…
- Fails to consent
- < 18 years old
- Hypertonic therapy not indicated
Where it is running
- Stanford University Hospital — Stanford, California, United States
Full record on ClinicalTrials.gov
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