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Life sciences · Journal article
Annals of Medicine · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a protocol for a planned but not yet executed randomized controlled trial testing high-dose inhaled nitric oxide (200 ppm) as adjunctive therapy in mechanically ventilated patients with severe pneumonia caused by multidrug-resistant bacteria. The trial will measure clinical pulmonary infection score change over 7 days as the primary endpoint, with secondary outcomes including mortality, organ failure, and bacterial eradication. No results are available; this document describes methods and hypotheses only.
Prospective, single-center, double-blind, randomized controlled trial. Patients admitted with suspected or confirmed severe pneumonia caused by multidrug-resistant bacteria who are mechanically ventilated.. Intervention: High-dose inhaled nitric oxide 200 ppm, twice daily for 30 minutes per session, for 5 days. Compared with: Standard treatment plus sham inhalation (0 ppm NO). n = 98. Single centre: Jiangdu People's Hospital Affiliated with Yangzhou University, Yangzhou, China.
Planned enrolment: n=98 patients randomized 1:1 to high-dose NO (200 ppm, twice daily 30 min/session for 5 days) or sham inhalation Primary outcome: change in Clinical Pulmonary Infection Score (CPIS) from baseline to day 7 Secondary outcomes include 28-day mortality, ventilator-free days, vasopressor-free days, ICU-free days, hospital-free days, and microbiological eradication
Primary endpoint (CPIS) is a clinical scoring system, not a hard outcome such as mortality or organ support-free days. Secondary outcomes include 28-day mortality, ventilator-free days, vasopressor-free days, ICU-free days, hospital-free days, and microbiological eradication
This protocol has no clinical impact yet because no results are reported. Once enrolled and completed, the trial will provide the first randomized controlled evidence on whether high-dose inhaled nitric oxide improves clinical outcomes in critically ill patients with MDR pneumonia, addressing a significant gap in treatment options for a high-mortality condition.
This is a published protocol for a prospective randomized controlled trial not yet completed; it describes planned methods and outcomes but reports no results, making it a hypothesis-generating document rather than evidence of efficacy.
As stated by the source record.
Quoted from the source exactly as published.
This protocol has no clinical impact yet because no results are reported. Once enrolled and completed, the trial will provide the first randomized controlled evidence on whether high-dose inhaled nitric oxide improves clinical outcomes in critically ill patients with MDR pneumonia, addressing a significant gap in treatment options for a high-mortality condition.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Introduction. Severe pneumonia caused by multidrug-resistant (MDR) bacteria is associated with high mortality. Inhaled nitric oxide (NO) has antimicrobial activity, but clinical evidence in MDR severe pneumonia remains limited. This trial will evaluate the efficacy and safety of adjunctive high-dose inhaled NO in patients with severe pneumonia associated with MDR bacteria.Patients and methods. This prospective, single-center, double-blind randomized controlled trial will be conducted at Jiangdu People's Hospital Affiliated with Yangzhou University from January 2026 to June 2027. Patients with suspected or confirmed severe pneumonia caused by MDR bacteria will be randomized 1:1 to standard treatment plus inhaled NO (200 ppm, twice daily for 30 min/session for 5 days) or standard treatment plus sham inhalation (0 ppm NO). The primary outcome is the change in Clinical Pulmonary Infection Score (CPIS) from baseline to day 7. Secondary outcomes include mortality, 28-day ventilator-free days, vasopressor-free days, antibiotic-free days, ICU-free days, and hospital-free days, CPIS and Sequential Organ Failure Assessment scores, microbiological eradication, citrullinated histone H3 and cell-free DNA concentrations, and ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ratios. Safety outcomes include methemoglobin and NO2 thresholds, serum creatinine, airway hyperreactivity, and acute kidney injury. Primary and secondary outcomes will be analyzed in confirmed MDR participants; safety will be assessed in participants receiving at least one study-gas administration.Discussion. This protocol tests a mechanistically plausible adjunctive therapy for MDR severe pneumonia. It will explore whether high-dose NO affects neutrophil extracellular trap activity.
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