Amantadine to Speed Awakening After Cardiac Arrest

Study Overview
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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.

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.

Official Title
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Amantadine to Speed Awakening After Cardiac Arrest

Conditions
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Coma, Heart Arrest, Anoxia

Intervention / Treatment
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* Drug: Amantadine
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube. | Drug: Placebo<br>* Placebo comparator<br>|
| Experimental: Amantadine<br>100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube. | Drug: Amantadine<br>* 100mg twice per day for 7 days at 0600 and 1200<br>* Other names: Symmetrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Awakening (Number of Patients Who Are Able to Follow Commands) | Defined as the ability to follow commands (i.e. wiggle your toes open your eyes squeeze my fingers. This corresponds to a Full Outline of Unresponsiveness motor score of 4. FOUR (full outline of unresponsiveness) measures the following: Eye Response, Motor Response, Brainstem Reflexes, and Respirations. | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Awakening | Defined as the time from enrollment to awakening | up to 28 days | 
| Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate) | detected by EEG monitoring with or without clinical correlate | during study drug administration (7 days) | 
| Nausea or Vomiting | nausea requiring antiemetic medications or clinical vomiting | during study drug administration (7 days) | 
| Number of Participants With Severe or Intracranial Bleeding | Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart arrest, resuscitation, seizures, hypothermia, induced, Amantadine