Cited by 890Respiratory Support and MechanismsAnesthesia and Sedative AgentsIntensive Care Unit Cognitive Disorders

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Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome

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The National Heart, Lung, and Blood Institute PETAL Clinical Trials Network·2019·New England Journal of Medicine

DOI 10.1056/nejmoa1901686PMC PMC6741345

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Abstract

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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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
DOI: 10.1056/nejmoa1901686
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
FWCI: 92.84
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
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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