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Amantadine to Speed Awakening After Cardiac Arrest (AWAKE)

J

Jon Rittenberger, MD

Status and phase

Completed
Phase 2

Conditions

Heart Arrest
Coma
Anoxia

Treatments

Drug: Amantadine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02486211
15GRNT25680021

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

14 participants in 2 patient groups, including a placebo group

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

Trial documents
1

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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