iNO300 Therapy in Critically Ill Patients With Pneumonia
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full description
This study is designed as a pilot, double-blinded, randomized controlled trial to investigate levels of methemoglobin in the treatment group versus the control group and efficacy of high dose inhaled NO among critically ill patients with pneumonia. We will enroll 34 adult patients with newly diagnosed pneumonia and invasive mechanical ventilation who are admitted to the ICUs at Massachusetts General Hospital.
After enrollment, participants will be randomized in 1:1 ratio to intervention group or control group. Baseline characteristics will be collected.
During treatment period, patients allocated to the intervention group will receive high dose inhaled NO starting at 250 ppm (not exceeding 300 ppm), 40min, 4 times daily, for 5 days. The control group will receive sham intervention. Both groups will receive standard therapy.
During follow-up period, we will follow participants for a total duration of 60 days. Methemoglobin kinetic levels and efficacy outcomes will be collected.
Enrollment
Sex
Ages
Volunteers
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
- Obvious signs of pregnancy (the third trimester) or active lactation.
- 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
- Documented history of left ventricular ejection fraction less than 30%
- Acute cardiogenic shock requiring inotropic or mechanical support with an ejection fraction less than 20%
- eGFR < 30 ml/min/1.73m^2 or use of continuous renal replacement therapy
- Platelet count less than 30,000/μl and/or high risk of bleeding
- A decision to do-not-resuscitate
- Enrollment in another experimental antimicrobial treatment protocol
Trial design
Primary purpose
Allocation
Interventional model
Masking
34 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Lorenzo Berra, MD; Run Dong, MD
Data sourced from clinicaltrials.gov
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