Amantadine to Speed Awakening After Cardiac Arrest

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2018

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.

Interventions

  • Drug: Amantadine
    • 100mg twice per day for 7 days at 0600 and 1200
  • Drug: Placebo
    • Placebo comparator

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
  • Experimental: Amantadine
    • 100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.

Clinical Trial Outcome Measures

Primary Measures

  • 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. FOUR (full outline of unresponsiveness) measures the following: Eye Response, Motor Response, Brainstem Reflexes, and Respirations.

Secondary Measures

  • Time to Awakening
    • 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
  • Nausea or Vomiting
    • Time Frame: during study drug administration (7 days)
    • nausea requiring antiemetic medications or clinical vomiting
  • Number of Participants With Severe or Intracranial Bleeding
    • Time Frame: 28 days
    • Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jon Rittenberger, MD
  • Collaborator
    • American Heart Association
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jon Rittenberger, MD, Associate Professor of Emergency Medicine – University of Pittsburgh
  • Overall Official(s)
    • Jon C Rittenberger, MD, Principal Investigator, University of Pittsburgh

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