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N Engl J Med. 2016 May 5;374(18):1711-22. doi: 10.1056/NEJMoa1514204. Epub 2016 Apr 4.

Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.

Collaborators (399)

Kerby JD, Wang HE, Bosarge PL Jr, Pittet JF, Stephens SW, Williams CR, Gray R, Gray P, Cobb G, Lowe R, Richardson D, Boyd S, Hallmark R, Wade D, West E, Underwood D, Hambright D, Gilford W, Christenson J, Connolly H, Pennington S, Hall C, Todorova D, Aguirre C, Schlamp R, Wand R, Straight R, Goulding J, Balfour N, Ganstal A, Idris AH, Fowler R, Miller R, Pepe P, Arellano-Cruz P, Bryant B, Castillo M, Climer D, Cooper T, Dickens A, Dudek S, Dykes K, Gallegos D, Howerton D, Moffat M, Owens P, Podias C, Ray D, Saniei S, Sledge B, Waks D, Zunner A, Beeson J, Benitez F, Corder S, Dees L, Deutsch S, Gamber M, Gamez G, Hamessley T, Heath S, Isaacs M, Kayea T, LaChance R, Lovato S, Martin L, McKee LA, Muse B, Navarro K, Price S, Richmond N, Rosenberger P, Seals N, Sides J, Swavey T, Tomasovic G, Wade M, Black S, Broders C, Bush M, Garrett J, Hum L, Oberg T, Ramsay M, Simonson R, Woodward P, Aufderheide TP, Pirrallo RG, Brasel KJ, Colella RM, Klein JP, Brandt J, Bialkowski W, Boettcher M, Jasti J, Gauger S, Sandoval C, Hermanson B, Burpee K, Price G, Hessenthaler A, Mena M, Zellner S, Quering B, Jasti J, Goldberg M, Herdeman C, Zeisse M, Qaisar T, Von Rueden W, Wuerl A, Mccormick K, Emmrich A, Hansen K, Labinski J, Knight M, Clausel A, Schuster T, Drent A, Walsh P, Forster R, Pukansky L, Sternig K, Viel E, Gonzalez N, Chin E, Krueger K, Soderbeck W, Rukavina M, Szewczuga D, Funk R, Jacobsen G, Spitzer J, Francis D, Cohn J, Jankowski M, Whitaker R, Rohlfing M, Rosandish T, Remington A, Knitter J, Ugaste R, Saidler T, Zellmann K, Bane S, Mattrisch L, Butts L Jr, Riegg S, Bruss K, Case J, Mccoy G, Egner K, Lenz T, Ateyyah KA, Weston B, Trichler T, Li C, Tang L, Reminga T, Shepherd D, Holzhauer P, Rubin J, Skold C, Alvarez O, Harkins H, Barthell E, Haselow W, Yee A, Whitcomb J, Castro EE, Motarjeme S, Coogan P, Rader K, Glaspy J, Gerschke G, Croft H, Brin M, Wilson C, Johnson A, Kumprey W, Harmelink N, Swart G, Juern J, Milia D, Weigelt J, Kaslow O, Stiell I, Vaillancourt C, Wells GA, Yelle JD, Clement C, Lepage G, Banek J, Gerrard P, Whitham V, Marcantonio A, Gleeson A, Munkley D, Affleck A, Bradford P, Smith K, Ferron R, Lutz-Graul K, Pedulla J, Gale N, Gates W, Monas J, Mellow R, Hedges C, Poole L, Graham E, Callaway CW, Callaway CW, Brienza A, Condle J, Repine M, DiFiore S, Morgan M, Vargo P, Widmer D, Cavey S, Jackson N, Roth R, Campbell V, Pinchalk M, Traynor O, Seaman K, Daya MR, Schmidt TA, Griffiths DE, Zive DM, Kampp M, Nuttall J, Vandenheuvel K, Sidhu A, Le N, Stouffer J, Wittwer L, Muhr MD, Griffith J, Free C, Warden CR, Gorman K, Beeler T, Conway W, Newton C, Geiger C, Colvin J, Hollingsworth M, O'Brien D, Shertz M, Malone S, Keim E, Sahni R, DeHart S, Freedman S, Moreno R, Chin J, Snyder S, Boyce D, Welk A, Funk A, Murphy W, Charleston M, Stevens M, Schult E, Sullivan S, Getsfrid J, Hoskins G, Shields C, Bishop TJ, Albrich M, Carnevale T, Fedor P, Best B, Kummer K, Arnold K, Davis D, Vilke G, Aker DK, Garcia E, Haynes B, Dunford J, Norton V, Mebust D, Kramer M, Morikado L, Grad M, Linnik W, Carter S, Hare M, Kudenchuk PJ, Kudenchuk P, Rea T, Ragsdale S, Solberg D, Sampson D, Olsufka M, Perry S, Larsen J, Morrison LJ, Dorian P, Verbeek P, Cheskes S, Moran P, Byers A, Heckaden B, McLeod B, Emerson B, Harrison C, Falconer D, Braga D, Burgess G, Mueller H, Walker J, Bath K, Wernham L, Lewarne L, Chen L, Reymen M, Zielinski M, Common M, Kadic M, Gaudio M, Qovaizi M, Liu N, Gavrylyuk O, Oke P, D'Souza P, Lui S, Brown S, Mathew S, Perreira T, Benson A, Bodo A, Mokedanz D, Wright G, Mcauley G, Sage G, Rosswell L, Addley M, Norwicky R, Gorsline S, Driscoll S, McConnell S, Jones V, Beckett W, Baker A, Slutsky A, Lefeuvre C, Simone C, Scales D, McRitchie D, Letovsky EE, Clasky H, Hutchinson J, Bowen J, Meyer J, Chien J, Christian M, Welsford M, Ferguson N, Brooks S, Weisfeldt M, Ornato JP, Sopko G, Egan D, Lathrop D, Nickens PD, Wu C, Mitchell P, Shah M, Rosenberg E, Pearson G, May S, Nichol G, Powell J, Schmicker R, Leroux B, Brown S, Herren H, Sims K, Emerson S, Gest A, van Belle G, Carson J, Kirdpoo W, Bergsten-Buret B, Moore R, Berhorst J, Prince D, Torres C, Case E, Guffey D, Sanchez B, Zelnick L, Devlin SM, Van Ottingham L, Sears G.

Abstract

BACKGROUND:

Antiarrhythmic drugs are used commonly in out-of-hospital cardiac arrest for shock-refractory ventricular fibrillation or pulseless ventricular tachycardia, but without proven survival benefit.

METHODS:

In this randomized, double-blind trial, we compared parenteral amiodarone, lidocaine, and saline placebo, along with standard care, in adults who had nontraumatic out-of-hospital cardiac arrest, shock-refractory ventricular fibrillation or pulseless ventricular tachycardia after at least one shock, and vascular access. Paramedics enrolled patients at 10 North American sites. The primary outcome was survival to hospital discharge; the secondary outcome was favorable neurologic function at discharge. The per-protocol (primary analysis) population included all randomly assigned participants who met eligibility criteria and received any dose of a trial drug and whose initial cardiac-arrest rhythm of ventricular fibrillation or pulseless ventricular tachycardia was refractory to shock.

RESULTS:

In the per-protocol population, 3026 patients were randomly assigned to amiodarone (974), lidocaine (993), or placebo (1059); of those, 24.4%, 23.7%, and 21.0%, respectively, survived to hospital discharge. The difference in survival rate for amiodarone versus placebo was 3.2 percentage points (95% confidence interval [CI], -0.4 to 7.0; P=0.08); for lidocaine versus placebo, 2.6 percentage points (95% CI, -1.0 to 6.3; P=0.16); and for amiodarone versus lidocaine, 0.7 percentage points (95% CI, -3.2 to 4.7; P=0.70). Neurologic outcome at discharge was similar in the three groups. There was heterogeneity of treatment effect with respect to whether the arrest was witnessed (P=0.05); active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest. More amiodarone recipients required temporary cardiac pacing than did recipients of lidocaine or placebo.

CONCLUSIONS:

Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT01401647.).

PMID:
27043165
DOI:
10.1056/NEJMoa1514204
[PubMed - indexed for MEDLINE]
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