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Amantadine to Speed Awakening After Cardiac Arrest (AWAKE)

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ClinicalTrials.gov Identifier: NCT02486211
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jon Rittenberger, MD, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coma Heart Arrest Anoxia Drug: Amantadine Drug: Placebo Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amantadine to Speed Awakening After Cardiac Arrest
Study Start Date : September 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Drug: Placebo
Placebo comparator

Experimental: Amantadine
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Drug: Amantadine
100mg BID for 7 days at 0600 and 1200
Other Name: Symmetrel




Primary Outcome Measures :
  1. Rate of awakening (Number of patients who are able to follow commands) [ Time Frame: up to 28 days ]
    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.


Secondary Outcome Measures :
  1. Time to awakening (time from resuscitation, in days, to following commands) [ Time Frame: up to 28 days ]
    Defined as the time from enrollment to awakening

  2. seizures (Number of patients who experience seizures as detected by EEG monitoring with or without clinical correlate) [ Time Frame: during study drug administration (7 days) ]
    detected by EEG monitoring with or without clinical correlate

  3. bleeding: severe or intracranial (Bleeding that does not stop with direct pressure, requires transfusion or occurs in the intracranial vault) [ Time Frame: during study drug administration (7 days) ]
    any bleeding that does not stop with direct pressure or requires transfusion, any bleeding in the intracranial vault

  4. nausea or vomiting (Nausea requiring antiemetic medications or clinically apparent vomiting) [ Time Frame: during study drug administration (7 days) ]
    nausea requiring antiemetic medications or clinical vomiting



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486211


Locations
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United States, Maine
Main Medical Center
Portland, Maine, United States, 04101
United States, Massachusetts
Beth Israel Deacconness
Boston, Massachusetts, United States, 02215
United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15216
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
Jon Rittenberger, MD
American Heart Association
Investigators
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Principal Investigator: Jon C Rittenberger, MD University of Pittsburgh

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Responsible Party: Jon Rittenberger, MD, Associate Professor of Emergency Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02486211     History of Changes
Other Study ID Numbers: 15GRNT25680021
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Keywords provided by Jon Rittenberger, MD, University of Pittsburgh:
heart arrest
resuscitation
seizures
hypothermia, induced
Amantadine
Additional relevant MeSH terms:
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Amantadine
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents