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Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome.
|Title||Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome.|
|Publication Type||Journal Article|
|Year of Publication||2019|
|Authors||Moss 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 Authors||National Heart, Lung, and Blood Institute PETAL Clinical Trials Network|
|Journal||N Engl J Med|
|Date Published||2019 05 23|
|Keywords||Adult, 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|
BACKGROUND: The benefits of early continuous neuromuscular blockade in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation remain unclear.
METHODS: 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
RESULTS: 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.
CONCLUSIONS: 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.).
|Alternate Journal||N. Engl. J. Med.|
|Grant List||U01HL123023 / 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