Clinical Trial: Amantadine to Speed Awakening After Cardiac Arrest

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Amantadine to Speed Awakening After Cardiac Arrest

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.

Detailed Summary:

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.


Sponsor: University of Pittsburgh

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: June 23, 2015
Date Started: September 2015
Date Completion: June 2017
Last Updated: January 3, 2017
Last Verified: January 2017