What this study is
The goal of this clinical trial is to learn the formation and recovery rate of methemoglobin (MetHb) in severely sick patients with pneumonia who receive high doses of inhaled nitric oxide (iNO) therapy at 250 parts per million (ppm), not exceeding 300 ppm. Meanwhile, the benefits of the therapy to treat severely sick patients with pneumonia will be explored. Patients who are 18 years or older, newly diagnosed with pneumonia, and severely sick with requirement of a breathing machine could be included. The main questions it aims to answer are:
How does methemoglobin change through the iNO treatment? Does iNO therapy increase the number of patients recovering from pneumonia? Researchers will compare iNO treatment to placebo, which means using the same device as the treatment group without delivering the study drug.
Participants will:
- Receive iNO treatment starting at 250 ppm, not exceeding 300 ppm, 40 min, every 6 hours, from day 1 to day 5
- Be followed up for 60 days
What's being tested
- High dose inhaled nitric oxide
Intervention · DRUG
Inhaled nitric oxide starting at 250-300 ppm, 40min, every 6 hours, from day 1 to day 5. Nitric oxide is delivered using a gas cylinder containing nitric oxide and nitrogen.
- Sham treatment
Intervention · OTHER
Sham intervention with the nitric oxide gas cylinder replaced by that containing only nitrogen and all other delivery procedures identical to the intervention group
- standard therapy
Intervention · OTHER
Standard therapy pneumonia and critical illness
Study details
- Official title
- High Dose Inhaled Nitric Oxide Therapy in Critically Ill Patients With Pneumonia: a Pilot, Double-blinded, Randomized, Controlled Trial
- Sponsor
- Massachusetts General Hospital
- Conditions
- Critical Illness · Pneumonia
- Enrolling
- 34 people
- Starts
- 2026-02-23
- Est. completion
- 2026-12
- Design
- Quadruple-blind, randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Run Dong · Contact6172563916rdong2@mgh.harvard.edu
Recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2025P000909
Principal investigator
Lorenzo Berra, MD
Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.