High-dose inhaled nitric oxide for adults with severe pneumonia on ventilators
Official title: High Dose Inhaled Nitric Oxide Therapy in Critically Ill Patients With Pneumonia: a Pilot, Double-blinded, Randomized, Controlled Trial
Run by Massachusetts General Hospital · NCT06950294 · Data updated 2026-11-12
This study will test whether short courses of high-dose inhaled nitric oxide help adults on ventilators with severe pneumonia recover and how the treatment affects methemoglobin levels.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | February 23, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT06950294 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are intubated and mechanically ventilated within 72 hours of a new diagnosis of community- or hospital-acquired pneumonia and who (or whose legally authorized representative) can provide informed consent are ideal candidates.
✕Probably not a fit
Patients with baseline methemoglobin ≥3%, certain genetic red blood cell disorders (e.g., G6PD deficiency, cytochrome b5 reductase deficiency, sickle cell), severe anemia, advanced renal failure, those already receiving inhaled NO, or those with DNR orders are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot is a double-blind, randomized, sham-controlled trial enrolling 34 mechanically ventilated adults with newly diagnosed community- or hospital-acquired pneumonia at Massachusetts General Hospital. Participants are randomized 1:1 to receive high-dose inhaled nitric oxide (starting at 250 ppm, not exceeding 300 ppm) for 40 minutes four times daily for five days or a sham intervention, alongside standard care. The study will closely monitor methemoglobin kinetics and safety during treatment and collect clinical efficacy outcomes. All participants are followed for 60 days to capture recovery and clinical course.
Why it matters
Potential benefit: If successful, the therapy could shorten time to recovery from severe pneumonia and define a safe high-dose inhaled nitric oxide dosing approach for ventilated patients.
How similar studies have gone: Lower-dose inhaled nitric oxide has improved oxygenation in some critical care settings and small reports suggest possible antimicrobial effects, but high-dose regimens for pneumonia remain novel and not yet well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Intubated and mechanically ventilated * Within 72h of diagnosis of community- or hospital-acquired pneumonia * Written informed consent obtained from patients or legally authorized representatives Exclusion Criteria: * Baseline methemoglobin 3% or higher * Genetic diseases including glucose-6-phosphate dehydrogenase deficiency, cytochrome b5 reductase deficiency, sickle cell disease * Oxygen saturation \< 88% on 100% inspired fraction of oxygen * Anemia with hemoglobin \< 7.0 g/dl * Acute cardiogenic shock requiring inotropic or mechanical support with an ejection fraction less than 20% * Receiving inhaled NO therapy or decision to initiate inhaled NO therapy within 24 hours post randomization * A decision to do-not-resuscitate (DNR) * Enrollment in another experimental antimicrobial treatment protocol * Patients for whom follow-up is expected to be impossible
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Lorenzo Berra, MD — Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
- Study coordinator: Lorenzo Berra, MD
- Email: lberra@mgh.harvard.edu
- Phone: 617-726-3030
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Respiratory Physiotherapy in Critically Ill Pneumonia Patients
This study tests whether a structured breathing and chest therapy program can change inflammatory biomarkers in adults with pneumonia in the ICU compared to usual care.
-
Sodium bicarbonate with bedside electrical impedance tomography to map lung blood flow in ventilated adults
This project will try whether a small sodium bicarbonate injection combined with bedside electrical impedance tomography can map lung blood flow in adults on mechanical ventilation, compared with hypertonic saline.
-
Effects of suctioning on pain and stress in intubated ICU patients
This study is testing if suctioning the breathing tube in ICU patients causes more pain and stress compared to not suctioning.
-
Predicting Extubation Problems With Machine Learning
This study tests whether computer models can predict extubation failure in adults on ventilators in the ICU.
-
Levetiracetam Dosing in Critically Ill on CRRT
This study tests how levetiracetam behaves in the bodies of adults on continuous renal replacement therapy to help figure out the best dosing.
-
Immersive VR for improving upper limb function in critically ill ICU patients
This trial tests whether fully immersive virtual reality training added to standard ICU rehabilitation can help improve upper limb strength and coordination in adults with ICU-acquired weakness.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.