EBQ:Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest
Neither amiodarone nor lidocaine resulted in a significantly higher survival rate or favorable neurologic outcome among patients with OHCA due to initial shock-refractory Vfib or pulseless Vtach. There was, however, heterogeneity of treatment effect with respect to whether the arrest was witnessed or not; both drugs were associated with a significant increase in survival rate amongst patient's whose arrest was bystander-witnessed.
OHCA arrest takes more than 300,000 lives ever year in the United States, with many of these due to Vfib or Vtach. Since, prehospital care is essential to improving survival for these patients, the medical community looks in this study to determine the effectiveness of currently used drugs for these conditions. Current ACLS standards entail the use of Amiodarone or Lidocaine for cardiac arrest secondary to ventricular fibrillation or pulseless ventricular tachycardia. While many studies have shown improved ROSC with use of these drugs, none yet have definitively spoken to improved hospital discharge or neurologic outcome. While this study did not show a survival benefit for either drug, sub group analysis suggests a benefit in witnessed OHCA.
- Randomized, double blinded placebo controlled trial
- Paramedics from 55 EMS services
- 10 sites across North America, part of the Resuscitation Outcomes Consortium (ROC)
- No major differences amongst the three groups with respect to baseline patients demographics.
- Patients 18 years of age or older + non traumatic OHCA + shock refractory ventricular fibrillation or pulseless ventricular tachycardia.
- Patients needed to have IV or IO access
- Patients who had already received open label medications
- Known hyper sensitivity to one of the trial drugs
- Group 1: Amiodarone 300 mg. A additional dose of 150 mg was given if rhythm was not terminated.
- Group 2: Lidocaine 120 mg. An additional dose of 60 mg was given if rhythm was not terminated.
- Group 3: Normal Saline (control group)
Survival to Hospital Discharge
- Amiodarone 237/970 (24.4%)
- Lidocaine 233/985 (23.7%)
- Placebo 222/1056 (21%)
When comparing the interventions head to head, no significant ARR was found:
- Amio vs. Placebo ARR 3.2 (P Value 0.08)
- Lido vs. Placebo ARR 2.6 (P Value 0.16)
- Amio vs. Lido ARR 0.7 (P Value 0.7)
Survival with a favorable neurologic outcome (Modified Rankin < 3). No significant differences were found:
- Amiodarone 18.8%
- Lidocaine 17.5%
- Placebo 16.6%
Bystander Witnessed Arrest was notable for a statistically significant increase in survival to discharge for both Amio and Lidocaine compared to placebo. No difference between the two active drugs were noted.
- Amiodarone 27.7%
- vs. placebo ARR 5% (P 0.04)
- Lidocaine 27.8%
- vs. placebo ARR 5.2% (P 0.03)
- Placebo 22.7%
EMS Witnessed Arrest was notable for a statistically significant increase in survival in the amiodarone group vs placebo.
- Amiodarone 38.6%
- vs. placebo ARR 21.9 (P 0.01)
- Lidocaine 23.3%
- Placebo 16.7%
Criticisms & Further Discussion
- Trial may be underpowered to detect a statistically significant result.
- The 3% difference in survival may be clinically significant, even though not statistically.
- Some results seem puzzling, such as the Lidocaine group having lower survival odds with EMS witnessed vs bystander or overall Lidocaine group.
- As the subgroup analysis suggests, there may be a benefit in particular cardiac arrest patients for these drugs (e.g. witnessed) - so further trials should isolate these demographics and confirm the results.
- The Bottom Line - ALPS Study
- R.E.B.E.L.E.M ALPS: Amiodarone, Lidocaine or Placebo Study in OCHA
- EM Lit of Note: Amiodarone, Lidocaine or...Nothing
- ACLS (Main)
- Adult pulseless arrest
- EBQ:Trial of Continuous or Interrupted Chest Compressions during CPR
The trial was sponsored by the NHLBI, the Canadian Institutes of Health Research. Baxter Healthcare provided all the drugs.