Amantadine to Speed Awakening After Cardiac Arrest

Phase 2

Completed

• Conditions: Heart Arrest; Coma; Anoxia
• Interventions: Drug: Placebo; Drug: Amantadine

• Registration Number: NCT02486211
• Lead Sponsor: Jon Rittenberger, MD

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.

Study Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-01
• Study Start: 2015-09
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Results First Submitted: 2019-06-28
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-18
• Last Update Submitted: 2019-11-18
• Results First Posted: 2019-12-04
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Amantadine	Amantadine	100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.

Primary Outcome Measures

Name	Time	Method
Rate of Awakening (Number of Patients Who Are Able to Follow Commands)	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 Outcome Measures

Name	Time	Method
Nausea or Vomiting	during study drug administration (7 days)	nausea requiring antiemetic medications or clinical vomiting
Time to Awakening	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)	during study drug administration (7 days)	detected by EEG monitoring with or without clinical correlate
Number of Participants With Severe or Intracranial Bleeding	28 days	Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault

Trial Locations

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