Amantadine to Speed Awakening After Cardiac Arrest

Jon Rittenberger, MD14 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Coma Heart Arrest Anoxia

Interventions

AmantadineDRUG

100mg twice per day for 7 days at 0600 and 1200

PlaceboDRUG

Placebo comparator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Main Medical Center

Portland, Maine, United States

Beth Israel Deacconness

Boston, Massachusetts, United States

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: up to 28 days

Secondary Outcomes

Time to Awakening

Defined as the time from enrollment to awakening

Time frame: up to 28 days

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

Time frame: during study drug administration (7 days)

Nausea or Vomiting

nausea requiring antiemetic medications or clinical vomiting

Time frame: during study drug administration (7 days)

Number of Participants With Severe or Intracranial Bleeding

Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault

Time frame: 28 days

Data from ClinicalTrials.gov

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