American journal of respiratory and critical care medicine
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Am. J. Respir. Crit. Care Med. · Dec 2019
Randomized Controlled Trial Multicenter StudySafety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe COPD (AIRFLOW): A Multicenter Randomized Controlled Trial.
Rationale: Targeted lung denervation (TLD) is a bronchoscopic radiofrequency ablation therapy for chronic obstructive pulmonary disease (COPD), which durably disrupts parasympathetic pulmonary nerves to decrease airway resistance and mucus hypersecretion. Objectives: To determine the safety and impact of TLD on respiratory adverse events. Methods: We conducted a multicenter, randomized, sham bronchoscopy-controlled, double-blind trial in patients with symptomatic (modified Medical Research Council dyspnea scale score, ≥2; or COPD Assessment Test score, ≥10) COPD (FEV1, 30-60% predicted). ⋯ There was no statistical difference in the time to first moderate or severe COPD exacerbation, patient-reported symptoms, or other physiologic measures over the 12.5 months of follow-up. Conclusions: Patients with symptomatic COPD treated with TLD combined with optimal pharmacotherapy had fewer study-defined respiratory adverse events, including hospitalizations for COPD exacerbation. Clinical trial registered with www.clinicaltrials.gov (NCT02058459).
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Am. J. Respir. Crit. Care Med. · Dec 2019
Randomized Controlled Trial Comparative Study Pragmatic Clinical TrialBalanced Crystalloids Versus Saline in Sepsis: A Secondary Analysis of the SMART Trial.
Rationale: Administration of intravenous crystalloid solutions is a fundamental therapy for sepsis, but the effect of crystalloid composition on patient outcomes remains unknown. Objectives: To compare the effect of balanced crystalloids versus saline on 30-day in-hospital mortality among critically ill adults with sepsis. Methods: Secondary analysis of patients from SMART (Isotonic Solutions and Major Adverse Renal Events Trial) admitted to the medical ICU with an International Classification of Diseases, 10th Edition, Clinical Modification System code for sepsis, using multivariable regression to control for potential confounders. ⋯ Patients in the balanced group experienced a lower incidence of major adverse kidney events within 30 days (35.4% vs. 40.1%; aOR, 0.78; 95% CI, 0.63-0.97) and a greater number of vasopressor-free days (20 ± 12 vs. 19 ± 13; aOR, 1.25; 95% CI, 1.02-1.54) and renal replacement therapy-free days (20 ± 12 vs. 19 ± 13; aOR, 1.35; 95% CI, 1.08-1.69) compared with the saline group. Conclusions: Among patients with sepsis in a large randomized trial, use of balanced crystalloids was associated with a lower 30-day in-hospital mortality compared with use of saline. Clinical trial registered with www.clinicaltrials.gov (NCT02444988).