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

Stanford University

Status and phase: Withdrawn; Early Phase 1

Conditions: Cerebral Edema; Saline Solution, Hypertonic

Treatments: Drug: 3% Sodium Chloride; Drug: 8.4% Sodium Bicarbonate; Drug: 23.4% Sodium Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03330704

IRB-43653

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Standard Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: 3% Sodium Chloride

Balanced Therapy

Experimental group

Description:

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

Treatment:

Drug: 23.4% Sodium Chloride

Drug: 8.4% Sodium Bicarbonate