Heart Arrest Clinical Trial
— AWAKEOfficial title:
Amantadine to Speed Awakening After Cardiac Arrest
Verified date | November 2019 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deacconness | Boston | Massachusetts |
United States | UPMC Mercy Hospital | Pittsburgh | Pennsylvania |
United States | UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania |
United States | Main Medical Center | Portland | Maine |
Lead Sponsor | Collaborator |
---|---|
Jon Rittenberger, MD | American Heart Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | up to 28 days | |
Secondary | Time to Awakening | Defined as the time from enrollment to awakening | up to 28 days | |
Secondary | 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 | during study drug administration (7 days) | |
Secondary | Nausea or Vomiting | nausea requiring antiemetic medications or clinical vomiting | during study drug administration (7 days) | |
Secondary | Number of Participants With Severe or Intracranial Bleeding | Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault | 28 days |
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