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Amantadine to Speed Awakening After Cardiac Arrest (AWAKE)

Primary Purpose

Coma, Heart Arrest, Anoxia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amantadine
Placebo
Sponsored by
Jon Rittenberger, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coma focused on measuring heart arrest, resuscitation, seizures, hypothermia, induced, Amantadine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Main Medical Center
  • Beth Israel Deacconness
  • UPMC Presbyterian Hospital
  • UPMC Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Amantadine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Awakening
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)
detected by EEG monitoring with or without clinical correlate
Nausea or Vomiting
nausea requiring antiemetic medications or clinical vomiting
Number of Participants With Severe or Intracranial Bleeding
Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault

Full Information

First Posted
June 23, 2015
Last Updated
November 18, 2019
Sponsor
Jon Rittenberger, MD
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT02486211
Brief Title
Amantadine to Speed Awakening After Cardiac Arrest
Acronym
AWAKE
Official Title
Amantadine to Speed Awakening After Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jon Rittenberger, MD
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coma, Heart Arrest, Anoxia
Keywords
heart arrest, resuscitation, seizures, hypothermia, induced, Amantadine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Arm Title
Amantadine
Arm Type
Experimental
Arm Description
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Intervention Type
Drug
Intervention Name(s)
Amantadine
Other Intervention Name(s)
Symmetrel
Intervention Description
100mg twice per day for 7 days at 0600 and 1200
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Rate of Awakening (Number of Patients Who Are Able to Follow Commands)
Description
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.
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Time to Awakening
Description
Defined as the time from enrollment to awakening
Time Frame
up to 28 days
Title
Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate)
Description
detected by EEG monitoring with or without clinical correlate
Time Frame
during study drug administration (7 days)
Title
Nausea or Vomiting
Description
nausea requiring antiemetic medications or clinical vomiting
Time Frame
during study drug administration (7 days)
Title
Number of Participants With Severe or Intracranial Bleeding
Description
Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon C Rittenberger, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Main Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Beth Israel Deacconness
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15216
Country
United States
Facility Name
UPMC Mercy Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States

12. IPD Sharing Statement

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