"Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome".The New England Journal of Medicine. 2019. 380(21):1997-2008.
Links to original sources: Wiki Journal Post Full Journal Article
Contents
1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
Does the addition of early continuous neuromuscular blockade with concomitant deep sedation reduce in-hospital mortality at 90 days compared with usual care with lighter sedation targets in patients with moderate-to-severe acute respiratory distress syndrome (ARDS)?
Among patients with moderate-to-severe ARDS, the addition of early continuous neuromuscular blockade with concomitant deep sedation did not result in a significant difference in mortality at 90 days compared to usual care with lighter sedation targets.
Neuromuscular blocking agents are sometimes used in patients with ARDS to improve oxygenation and patient-ventilator synchronization. However, these benefits need to be weighed against potential side effects, including muscle weakness. The Reevaluation of Systemic Early Neuromuscular Blockade (ROSE) trial sought to assess whether early continuous infusion of cisatracurium would improve 90-day in-hospital mortality compared to standard care without routine neuromuscular blockade and lighter sedation targets. The trial found no significant difference in mortality between the two groups.
As of 2019, guidelines for the management of ARDS do not yet reflect the results of the ROSE trial.
- Multicenter, randomized, unblinded clinical trial - N=1,006 patients with moderate-to-severe ARDS - Intervention group received 48-hour continuous infusion of cisatracurium with concomitant deep sedation - Control group received usual care without routine neuromuscular blockade and lighter sedation targets - Primary outcome: In-hospital mortality at 90 days - Trial was stopped early for futility based on the second interim analysis
- Inclusion Criteria: Patients under mechanical ventilation for less than 48 hours for moderate-to-severe ARDS - Exclusion Criteria: Various, including cardiac failure or fluid overload as the primary cause of respiratory failure; see full list in the Supplementary Appendix of the original study - Baseline Characteristics: Similar in both groups
- Intervention group: 48-hour continuous infusion of cisatracurium with deep sedation - Control group: Standard care including lighter sedation targets - Same ventilation strategies, including high PEEP, used in both groups
- Primary Outcome: In-hospital death from any cause at 90 days. 42.5% in the intervention group and 42.8% in the control group (between-group difference, −0.3 percentage points; 95% CI, −6.4 to 5.9; P=0.93) - Secondary Outcomes: Similar between groups in terms of days free of organ dysfunction, days not in ICU, days free of mechanical ventilation, and days not hospitalized at day 28.
- Early exclusion of eligible patients who had previously received neuromuscular blockade could have affected results. - Treatment was not blinded, potentially influencing assessments of muscle strength and the level of physical activity. - Possible underuse of prone positioning, which has been shown to reduce mortality in ARDS, might have influenced results.
- Supported by grants from the National Heart, Lung, and Blood Institute.
- Full NEJM article and supplementary material at NEJM.org.