Clin Exp Emerg Med.
2024 Jun;11(2):205-212. 10.15441/ceem.23.158.
A multicenter, randomized, doubleblind, placebo-controlled trial of amantadine to stimulate awakening in comatose patients resuscitated from cardiac arrest
- Coppler PJ
1 - Gagnon DJ2
- Flickinger KL1
- Elmer J1,3,4
- Callaway CW1
- Guyette FX1
- Doshi A1
- Steinberg A1,3,4
- Dezfulian C5
- Moskowitz AL6
- Donnino M7
- May TL2
- Seder DB2
- Rittenberger JC8
- Affiliations
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- 1Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA
- 2Department of Critical Care Services, Maine Medical Center, Portland, ME, USA
- 3Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, USA
- 4Department of Neurology, University of Pittsburgh, Pittsburgh, PA, USA
- 5Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA
- 6Department of Medicine, Albert Einstein College of Medicine, New York, NY, USA
- 7Department of Medicine, Beth Israel Deaconess, Boston, MA, USA
- 8Department of Emergency Medicine, Geisinger Commonwealth School of Medicine, Scranton, PA, USA
- KMID: 2557262
- DOI: http://doi.org/10.15441/ceem.23.158
Abstract
Objective
We hypothesized that the administration of amantadine would increase awakening of comatose patients resuscitated from cardiac arrest. Methods We performed a prospective, randomized, controlled pilot trial, randomizing subjects to amantadine 100 mg twice daily or placebo for up to 7 days. The study drug was administered between 72 and 120 hours after resuscitation and patients with absent N20 cortical responses, early cerebral edema, or ongoing malignant electroencephalography patterns were excluded. Our primary outcome was awakening, defined as following two-step commands, within 28 days of cardiac arrest. Secondary outcomes included length of stay, awakening, time to awakening, and neurologic outcome measured by Cerebral Performance Category at hospital discharge. We compared the proportion of subjects awakening and hospital survival using Fisher exact tests and time to awakening and hospital length of stay using Wilcoxon rank sum tests. Results After 2 years, we stopped the study due to slow enrollment and lapse of funding. We enrolled 14 subjects (12% of goal enrollment), seven in the amantadine group and seven in the placebo group. The proportion of patients who awakened within 28 days after cardiac arrest did not differ between amantadine (n=2, 28.6%) and placebo groups (n=3, 42.9%; P>0.99). There were no differences in secondary outcomes. Study medication was stopped in three subjects (21.4%). Adverse events included a recurrence of seizures (n=2; 14.3%), both of which occurred in the placebo group. Conclusion We could not determine the effect of amantadine on awakening in comatose survivors of cardiac arrest due to small sample size.
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