iNO300 Therapy in Critically Ill Patients With Pneumonia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- High dose inhaled nitric oxide
- Sham treatment
- standard therapy
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov