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

Early Phase 1

Withdrawn

• Conditions: Cerebral Edema; Saline Solution, Hypertonic
• Interventions: Drug: 3% Sodium Chloride; Drug: 23.4% Sodium Chloride; Drug: 8.4% Sodium Bicarbonate

• Registration Number: NCT03330704
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Study Start: 2017-11-28
• Status Verified: 2019-02
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

• Fails to consent
• < 18 years old
• Hypertonic therapy not indicated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Therapy	3% Sodium Chloride	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.
Balanced Therapy	23.4% Sodium Chloride	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
Balanced Therapy	8.4% Sodium Bicarbonate	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

Primary Outcome Measures

Name	Time	Method
Total volume of intravenous hypertonic fluid administered to the patient	The fluid will be infused until the new serum sodium goal is achieved. This outcome measure will be assessed 1 week after study enrollment	Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid.

Secondary Outcome Measures

Name	Time	Method
Urine output	Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment	Urine output will be collected and measured quantitatively in milliliter units.

Trial Locations

Locations (1)

Stanford University Hospital; 🇺🇸 Stanford, California, United States