[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589121":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":40,"locations":48,"responsibleParty":66,"collaborators":27,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":27,"enrollmentInfo":78,"targetDuration":27,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":50,"whyStopped":27,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"iNO300 group","EXPERIMENTAL","High dose inhaled nitric oxide starting at 250 ppm (not exceeding 300 ppm) , 40min, 4 times daily, from day 1 to day 5. Nitric oxide is delivered using a gas cylinder containing nitric oxide and nitrogen.",[13,14],"Drug: High dose inhaled nitric oxide","Other: standard therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","SHAM_COMPARATOR","Sham intervention with the nitric oxide gas cylinder replaced by that containing only nitrogen and all other delivery procedures identical to the intervention group",[20,14],"Other: Sham treatment",[22,28,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","High dose inhaled nitric oxide","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.",[9],null,{"type":6,"name":29,"description":18,"armGroupLabels":30,"otherNames":27},"Sham treatment",[16],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":27},"standard therapy","Standard therapy pneumonia and critical illness",[16,9],[36],{"name":37,"affiliation":38,"role":39},"Lorenzo Berra, MD","Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital","PRINCIPAL_INVESTIGATOR",[41,45],{"name":37,"role":42,"phone":43,"phoneExt":27,"email":44},"CONTACT","617-726-3030","lberra@mgh.harvard.edu",{"name":46,"role":42,"phone":43,"phoneExt":27,"email":47},"Run Dong, MD","rdong2@mgh.harvard.edu",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-71.05977,42.35843,{"lat":60,"lon":59},[63],{"name":64,"role":42,"phone":65,"phoneExt":27,"email":47},"Run Dong","6172563916",{"type":39,"investigatorFullName":37,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Clinician Investigator, Associate Professor, Anesthesia, Critical Care and Pain Medicine, Mass General Research Institute","100589121","early-phase-1-ino300-therapy-in-critically-ill-patients-with-pneumonia-100589121",false,"NCT06950294","iNO300 Therapy in Critically Ill Patients With Pneumonia","High Dose Inhaled Nitric Oxide Therapy in Critically Ill Patients With Pneumonia: a Pilot, Double-blinded, Randomized, Controlled Trial","iNO300","Inclusion Criteria:\n\n* 18 years or older\n* Intubated and mechanically ventilated\n* Within 72h of diagnosis of community- or hospital-acquired pneumonia\n* Written informed consent obtained from patients or legally authorized representatives\n\nExclusion Criteria:\n\n* Baseline methemoglobin 3% or higher\n* Genetic diseases including glucose-6-phosphate dehydrogenase deficiency, cytochrome b5 reductase deficiency, sickle cell disease\n* Oxygen saturation \\\u003C 88% on 100% inspired fraction of oxygen\n* Anemia with hemoglobin \\\u003C 7.0 g\u002Fdl\n* Acute cardiogenic shock requiring inotropic or mechanical support with an ejection fraction less than 20%\n* Receiving inhaled NO therapy or decision to initiate inhaled NO therapy within 24 hours post randomization\n* A decision to do-not-resuscitate (DNR)\n* Enrollment in another experimental antimicrobial treatment protocol\n* Patients for whom follow-up is expected to be impossible","ALL","18 Years",{"count":79,"type":80},34,"ESTIMATED","INTERVENTIONAL",[83],"EARLY_PHASE1","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:\n\nHow 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.\n\nParticipants will:\n\n* Receive iNO treatment starting at 250 ppm, not exceeding 300 ppm, 40 min, every 6 hours, from day 1 to day 5\n* Be followed up for 60 days",[86,87],"Critical Illness","Pneumonia",[24,87,89,90],"Critical care","Methemoglobin","2026-05-20",{"date":93,"type":94},"2026-05-22","ACTUAL",{"date":96,"type":94},"2026-02-23",{"date":98,"type":80},"2026-12",{"name":5,"class":6},1]