Phase 2
N=14
Amantadine to Speed Awakening After Cardiac Arrest
Coma · Heart Arrest · Anoxia
Bottom Line
View on ClinicalTrials.gov: NCT02486211 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Rate of Awakening (Number of Patients Who Are Able to Follow Commands) — 2; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Amantadine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jon Rittenberger, MD
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Awakening (Number of Patients Who Are Able to Follow Commands) |
2; 2 | — |
| SECONDARY Time to Awakening |
4; 8 | — |
| SECONDARY Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate) |
0; 2 | — |
| SECONDARY Nausea or Vomiting |
0; 0 | — |
| SECONDARY Number of Participants With Severe or Intracranial Bleeding |
0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02486211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.