Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome

被引:536
作者
Moss, Marc [1 ]
Huang, David T. [3 ]
Brower, Roy G. [5 ]
Ferguson, Niall D. [6 ,7 ]
Ginde, Adit A. [2 ]
Gong, M. N. [8 ]
Grissom, Colin K. [9 ,10 ]
Gundel, Stephanie [11 ]
Hayden, Douglas [12 ]
Hite, R. Duncan [17 ]
Hou, Peter C. [15 ]
Hough, Catherine L. [11 ]
Iwashyna, Theodore J. [18 ,19 ]
Khan, Akram [20 ]
Liu, Kathleen D. [21 ,22 ]
Talmor, Daniel [16 ]
Thompson, B. Taylor [13 ]
Ulysse, Christine A. [14 ]
Yealy, Donald M. [4 ]
Angus, Derek C. [3 ]
机构
[1] Univ Colorado, Sch Med, Dept Med, Aurora, CO USA
[2] Univ Colorado, Sch Med, Dept Emergency Med, Aurora, CO USA
[3] Univ Pittsburgh, Sch Med, Dept Crit Care Med, Pittsburgh, PA USA
[4] Univ Pittsburgh, Sch Med, Dept Emergency Med, Pittsburgh, PA USA
[5] Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21205 USA
[6] Univ Hlth Network, Dept Med, Interdept Div Crit Care Med, Toronto, ON, Canada
[7] Univ Toronto, Sinai Hlth Syst, Toronto, ON, Canada
[8] Montefiore Hosp, Dept Med, New York, NY USA
[9] Intermt Med Ctr, Dept Med, Salt Lake City, UT USA
[10] Univ Utah, Salt Lake City, UT USA
[11] Univ Washington, Dept Med, Seattle, WA USA
[12] Massachusetts Gen Hosp, Biostat Ctr, Boston, MA 02114 USA
[13] Massachusetts Gen Hosp, Dept Med, Boston, MA 02114 USA
[14] Massachusetts Gen Hosp, PETAL Network Clin Coordinating Ctr, Boston, MA 02114 USA
[15] Brigham & Womens Hosp, Dept Emergency Med, Div Emergency Crit Care Med, 75 Francis St, Boston, MA 02115 USA
[16] Beth Israel Deaconess Med Ctr, Dept Anesthesia Crit Care & Pain Med, Boston, MA 02215 USA
[17] Cleveland Clin, Resp Inst, Dept Crit Care, Cleveland, OH 44106 USA
[18] Univ Michigan, Dept Med, Ann Arbor, MI 48109 USA
[19] Vet Affairs Ctr Clin Res, Ann Arbor, MI USA
[20] Oregon Hlth & Sci Univ, Dept Med, Portland, OR 97201 USA
[21] Univ Calif San Francisco, Dept Med, San Francisco, CA USA
[22] Univ Calif San Francisco, Dept Anesthesia, San Francisco, CA USA
关键词
MECHANICALLY VENTILATED PATIENTS; INTENSIVE-CARE UNIT; NONLINEAR IMPUTATION; BLOCKING-AGENTS; SEDATION; RELIABILITY; MORTALITY; ICU; AGITATION; WEAKNESS;
D O I
10.1056/NEJMoa1901686
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 <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. 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, .) This trial revisited research conducted about a decade ago that showed a survival benefit with early neuromuscular blockade in patients with acute respiratory distress syndrome. The new trial did not show a benefit with neuromuscular blockade with respect to overall survival or other clinical outcomes.
引用
收藏
页码:1997 / 2008
页数:12
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