ROC-ALPS (lidocaine)
Trial question
What is the role of lidocaine in patients with out-of-hospital cardiac arrest due to initial shock-refractory VF or pulseless VT?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 2052
2052 patients (392 female, 1660 male).
Inclusion criteria: adult patients who had nontraumatic out-of-hospital cardiac arrest, shock-refractory VF or pulseless VT after at least one shock, and vascular access.
Key exclusion criteria: receipt of open-label IV lidocaine or amiodarone during resuscitation; known hypersensitivity to study drugs.
Interventions
N=993 lidocaine (a total dose of 180 mg in lidocaine kit).
N=1059 placebo (normal saline kit).
Primary outcome
Survival to hospital discharge
23.7%
21%
23.7 %
17.8 %
11.8 %
5.9 %
0.0 %
Lidocaine
Placebo
No significant
difference ↔
No significant difference in survival to hospital discharge (23.7% vs. 21%; AD 2.6%, 95% CI -1 to 6.3).
Secondary outcomes
No significant difference in mRS score ≤ 3 (17.5% vs. 16.6%; AD 0.9%, 95% CI -2.4 to 4.2).
Significant increase in return of spontaneous circulation at emergency department arrival (39.9% vs. 34.6%; AD 5.4%, 95% CI 1.2 to 9.5).
Significant increase in hospital admission (47% vs. 39.7%; AD 7.4%, 95% CI 3.1 to 11.6).
Safety outcomes
No significant difference in drug-related adverse events or serious adverse events.
Conclusion
In adult patients who had nontraumatic out-of-hospital cardiac arrest, shock-refractory VF or pulseless VT after at least one shock, and vascular access, lidocaine was not superior to placebo with respect to survival to hospital discharge.
Reference
Peter J Kudenchuk, Siobhan P Brown, Mohamud Daya et al. Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. N Engl J Med. 2016 May 5;374(18):1711-22.
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