American journal of respiratory and critical care medicine
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Am. J. Respir. Crit. Care Med. · Dec 2023
Randomized Controlled Trial Multicenter StudyEarly Video Assisted Thoracoscopic Surgery (VATS) or Intrapleural Enzyme Therapy (IET) in Pleural Infection - A Feasibility Randomized Controlled Trial (The Third Multicenter Intrapleural Sepsis Trial - MIST-3).
Rationale: Assessing the early use of video-assisted thoracoscopic surgery (VATS) or intrapleural enzyme therapy (IET) in pleural infection requires a phase III randomized controlled trial (RCT). Objectives: To establish the feasibility of randomization in a surgery-versus-nonsurgery trial as well as the key outcome measures that are important to identify relevant patient-centered outcomes in a subsequent RCT. Methods: The MIST-3 (third Multicenter Intrapleural Sepsis Trial) was a prospective multicenter RCT involving eight U. ⋯ Despite the logistical challenges posed by the coronavirus disease (COVID-19) pandemic, the study met its predefined feasibility criteria, demonstrated potential shortening of length of stay with early surgery, and signals toward earlier resolution of pain and a shortened recovery with IET. The study findings suggest that a definitive phase III study is feasible but highlights important considerations and significant modifications to the design that would be required to adequately assess optimal initial management in pleural infection. The trial was registered on ISRCTN (number 18,192,121).
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Am. J. Respir. Crit. Care Med. · Dec 2023
Randomized Controlled Trial Multicenter StudyHigh-Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure due to COVID-19: A Multicenter Phase 2 Trial.
Rationale: The effects of high-dose inhaled nitric oxide on hypoxemia in coronavirus disease (COVID-19) acute respiratory failure are unknown. Objectives: The primary outcome was the change in arterial oxygenation (PaO2/FiO2) at 48 hours. The secondary outcomes included: time to reach a PaO2/FiO2.300mmHg for at least 24 hours, the proportion of participants with a PaO2/FiO2.300mmHg at 28 days, and survival at 28 and at 90 days. ⋯ Duration of ventilation and mortality at 28 and 90 days did not differ. No serious adverse events were reported. Conclusions: The use of high-dose inhaled nitric oxide resulted in an improvement of PaO2/FiO2 at 48 hours compared with usual care in adults with acute hypoxemic respiratory failure due to COVID-19.
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Am. J. Respir. Crit. Care Med. · Dec 2023
Letter Randomized Controlled Trial Multicenter StudyThe Interaction of Acute Kidney Injury with Resuscitation Strategy in Sepsis: A Secondary Analysis of a Multicenter, Phase 3, Randomized Trial (CLOVERS).