NCT03330704

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

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Edema
• Saline Solution, Hypertonic

Interventions

Type	Name	Description
DRUG	3% Sodium Chloride	3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
DRUG	23.4% Sodium Chloride	23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
DRUG	8.4% Sodium Bicarbonate	8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure

Timeline

• Start date: 2017-11-28
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2017-11-06
• Last updated: 2020-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study