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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2020-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Edema Saline Solution, Hypertonic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Standard Therapy

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.

Group Type ACTIVE_COMPARATOR

3% Sodium Chloride

Intervention Type DRUG

3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure

Balanced Therapy

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

Group Type EXPERIMENTAL

23.4% Sodium Chloride

Intervention Type DRUG

23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure

8.4% Sodium Bicarbonate

Intervention Type DRUG

8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure

Interventions

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3% Sodium Chloride

3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure

Intervention Type DRUG

23.4% Sodium Chloride

23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure

Intervention Type DRUG

8.4% Sodium Bicarbonate

8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Able to consent
* 18 years or older
* English speaking
* Clinical indication (intracranial hypertension from cerebral edema) for hypertonic fluid administration