Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-11-30

Brief Summary

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This study examines the role of osmotic agents in controlling brain swelling in brain injured individuals. Two osmotic agents -- mannitol and hypertonic saline -- are in common use, and they will be compared in the context of a randomized clinical trial. The goal is to determine if these agent differ in their ability to control episodes of brain swelling.

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Detailed Description

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This single-center, randomized, open label trial will compare (i) 0.9% normal saline infusion and boluses of mannitol (control group) with (ii) 3% hypertonic saline, with intermittent boluses as needed, to treat elevated intracranial pressure (ICP) following severe traumatic brain injury.

Patients will be randomized to one of the two study arms following placement of an ICP monitor. Raised ICP will be defined as an ICP greater than 20 mmHG for 20 minutes or longer. In the event of such an event, the appropriate treatment will be administered.

The primary endpoint will be success in ICP control, operationalized as the proportion of time during which ICP is less than or equal to 20 mmHg during the first 120 hours following initiation of monitoring. Secondary endpoints include therapy intensity level, incidence of pre-determined severe adverse events, and long-term outcomes measured at 3 and 6 months post-injury.

Conditions

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Traumatic Brain Injury Elevated Intracranial Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mannitol

0.9% normal saline infusion and boluses of mannitol

Group Type ACTIVE_COMPARATOR

Mannitol

Intervention Type DRUG

0.9% normal saline infusion and boluses of mannitol

Hypertonic Saline

3% hypertonic saline continuous infusion, with intermittent boluses as needed

Group Type ACTIVE_COMPARATOR

Hypertonic Saline

Intervention Type DRUG

3% hypertonic saline continuous infusion, with intermittent boluses as needed

Interventions

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Mannitol

0.9% normal saline infusion and boluses of mannitol

Intervention Type DRUG

Hypertonic Saline

3% hypertonic saline continuous infusion, with intermittent boluses as needed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* closed traumatic brain injury
* either (i) GCS score 3-8 (inclusive), or (ii) GCS motor score of 5 or less AND abnormal admission CT scan showing intracranial pathology
* hemodynamically stable with systolic blood pressure greater than 90 mmHg
* at least 1 reactive pupil
* age between 18y and 70y (inclusive)
* INR less than 1.5

Exclusion Criteria

* actively on hypertonic saline or mannitol
* hypernatremia (\>145 meq/L)
* anuric or with creatinine greater than or equal to 2.5
* known seizure disorder
* penetrating head trauma
* suspected anoxic events
* history of, or CT confirmation of, previous brain injury
* any injury that, in the opinion of the Principal Investigator, has a high likelihood of death with the first 72 hours post-injury
* any treatment, condition, or injury that contraindicates treatment with hypertonic saline

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No