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Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome.

TitleEarly Neuromuscular Blockade in the Acute Respiratory Distress Syndrome.
Publication TypeJournal Article
Year of Publication2019
AuthorsMoss M, Huang DT, Brower RG, Ferguson ND, Ginde AA, Gong MN, Grissom CK, Gundel S, Hayden D, R Hite D, Hou PC, Hough CL, Iwashyna TJ, Khan A, Liu KD, Talmor D, B Thompson T, Ulysse CA, Yealy DM, Angus DC
Corporate AuthorsNational Heart, Lung, and Blood Institute PETAL Clinical Trials Network
JournalN Engl J Med
Volume380
Issue21
Pagination1997-2008
Date Published2019 05 23
ISSN1533-4406
KeywordsAdult, Aged, Atracurium, Combined Modality Therapy, Conscious Sedation, Female, Hospital Mortality, Humans, Male, Middle Aged, Neuromuscular Blockade, Neuromuscular Blocking Agents, Positive-Pressure Respiration, Respiratory Distress Syndrome, Adult, Treatment Failure
Abstract

<p><b>BACKGROUND: </b>The benefits of early continuous neuromuscular blockade in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation remain unclear.</p><p><b>METHODS: </b>We randomly assigned patients with moderate-to-severe ARDS (defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of <150 mm Hg with a positive end-expiratory pressure [PEEP] of ≥8 cm of water) to a 48-hour continuous infusion of cisatracurium with concomitant deep sedation (intervention group) or to a usual-care approach without routine neuromuscular blockade and with lighter sedation targets (control group). The same mechanical-ventilation strategies were used in both groups, including a strategy involving a high PEEP. The primary end point was in-hospital death from any cause at 90 days.</p><p><b>RESULTS: </b>The trial was stopped at the second interim analysis for futility. We enrolled 1006 patients early after the onset of moderate-to-severe ARDS (median, 7.6 hours after onset). During the first 48 hours after randomization, 488 of the 501 patients (97.4%) in the intervention group started a continuous infusion of cisatracurium (median duration of infusion, 47.8 hours; median dose, 1807 mg), and 86 of the 505 patients (17.0%) in the control group received a neuromuscular blocking agent (median dose, 38 mg). At 90 days, 213 patients (42.5%) in the intervention group and 216 (42.8%) in the control group had died before hospital discharge (between-group difference, -0.3 percentage points; 95% confidence interval, -6.4 to 5.9; P = 0.93). While in the hospital, patients in the intervention group were less physically active and had more adverse cardiovascular events than patients in the control group. There were no consistent between-group differences in end points assessed at 3, 6, and 12 months.</p><p><b>CONCLUSIONS: </b>Among patients with moderate-to-severe ARDS who were treated with a strategy involving a high PEEP, there was no significant difference in mortality at 90 days between patients who received an early and continuous cisatracurium infusion and those who were treated with a usual-care approach with lighter sedation targets. (Funded by the National Heart, Lung, and Blood Institute; ROSE ClinicalTrials.gov number, NCT02509078.).</p>

DOI10.1056/NEJMoa1901686
Alternate JournalN. Engl. J. Med.
PubMed ID31112383
Grant ListU01HL123023 / HL / NHLBI NIH HHS / United States
K23 HL143053 / HL / NHLBI NIH HHS / United States
U01HL123031 / HL / NHLBI NIH HHS / United States
U01HL123020 / HL / NHLBI NIH HHS / United States
U01HL123010 / HL / NHLBI NIH HHS / United States
U01HL122998 / HL / NHLBI NIH HHS / United States
U01HL123027 / HL / NHLBI NIH HHS / United States
U01HL123018 / HL / NHLBI NIH HHS / United States
U01HL123009 / HL / NHLBI NIH HHS / United States
U01HL123008 / HL / NHLBI NIH HHS / United States
U01HL123022 / HL / NHLBI NIH HHS / United States
U01HL123033 / HL / NHLBI NIH HHS / United States
U01HL123004 / HL / NHLBI NIH HHS / United States
U01HL122989 / HL / NHLBI NIH HHS / United States