Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome
Open accessAbstract
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, NCT02509078.).
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Since then, several RCTs have been published, the largest of which is the ROSE Trial.
“Since then, several RCTs have been published [469–471], the largest of which is the ROSE Trial [471].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [471]
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- Authors
- The National Heart, L.
- Corresponding author
- The National Heart, Lung, and Blood Institute PETAL Clinical Trials Network
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-05-23
- Volume
- 380
- Issue
- 21
- Pages
- 1997-2008
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC6741345
- OpenAlex
- W2944755457
- Cited by
- 886
- References
- 47
- Citations by year
- 2026: 63 · 2025: 99 · 2024: 90 · 2023: 128 · 2022: 141 · 2021: 146 · 2020: 175 · 2019: 43 · 2018: 1
- FWCI
- 92.84
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Heart, Lung, and Blood Institute (U01HL122989, U01HL122998, U01HL123004, U01HL123008, U01HL123009, U01HL123010, U01HL123018, U01HL123020, U01HL123022, U01HL123023, U01HL123027, U01HL123031, U01HL123033)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Anesthesia and Sedative Agents
- Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Intensive Care Unit Cognitive Disorders
- Keywords
- acute respiratory distress syndrome, neuromuscular blockade, cisatracurium, mechanical ventilation, positive end-expiratory pressure, sedation, mortality, futility
- MeSH terms
- Adult, Aged, Atracurium, Combined Modality Therapy, Female, Humans, Male, Middle Aged, Neuromuscular Blocking Agents, Positive-Pressure Respiration, Respiratory Distress Syndrome, Conscious Sedation, Procedural Sedation, Hospital Mortality, Treatment Failure, Neuromuscular Blockade
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