Amantadine to Speed Awakening After Cardiac Arrest

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-06-30

Brief Summary

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This study evaluates if amantadine will increase the rate of awakening in patients resuscitated from cardiac arrest but comatose (not following commands) after their resuscitation. Half of the participants will receive amantadine and the other will receive placebo.

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Detailed Description

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Amantadine has been used to help patients awaken following traumatic brain injury, but it has not been studied in patients with anoxic brain injury.

Amantadine is a dopamine agonist and may help with stimulating the brain to awaken. The investigators will randomize subjects who remain comatose 72 hours following resuscitation from cardiac arrest to either amantadine or placebo. They will be treated with either amantadine or placebo for 7 days.

Conditions

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Coma Heart Arrest Anoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator

Amantadine

100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.

Group Type EXPERIMENTAL

Amantadine

Intervention Type DRUG

100mg twice per day for 7 days at 0600 and 1200

Interventions

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Amantadine

100mg twice per day for 7 days at 0600 and 1200

Intervention Type DRUG

Placebo

Placebo comparator

Intervention Type DRUG

Other Intervention Names

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Symmetrel

Eligibility Criteria

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Inclusion Criteria

* Non traumatic cardiac arrest
* Age 18 and older
* Defibrillation and/or chest compressions by healthcare providers
* Return of spontaneous circulation

Exclusion Criteria

* Written do not attempt resuscitation (DNAR) reported to providers before randomization
* Known prisoner or pregnancy
* Lack of motor response to pain and absent N20 response on somatosensory evoked potentials prior to randomization
* Initial CT demonstrating brain edema (defined as grey white ratio \<1.2)
* Presence of malignant pattern on EEG at time of randomization
* Next of kin unwilling to provide supportive care for at least one week after enrollment
* Presently using other dopaminergic agent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No