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Vasodilator
Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension
Phase < 1
Waitlist Available
Led By Yuri Matusov, MD
Research Sponsored by Yuri Matusov
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Mechanically ventilated
Must not have
Primary cardiogenic shock
Presence of pre-existing significant valvular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 days
Awards & highlights
No Placebo-Only Group
Summary
"This trial is studying the use of inhaled nitric oxide for patients who develop pulmonary hypertension during Acute Respiratory Distress Syndrome. The goal is to see if giving nitric oxide early in the
Who is the study for?
This trial is for patients with ARDS who are starting to show signs of high blood pressure in the lungs. It's open to those who haven't yet received treatment for this specific complication.
What is being tested?
The study tests if inhaling nitric oxide (iNO) early on can help manage increased lung blood pressure and improve overall health in ARDS patients.
What are the potential side effects?
Inhaled nitric oxide may cause headaches, dizziness, or a rise in methemoglobin levels which reduces oxygen delivery by blood.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am on a mechanical ventilator.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a severe heart condition that affects its ability to pump blood.
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I have a serious heart valve condition.
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I have a heart condition affecting my heart's muscle.
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I had moderate to severe lung blood pressure issues before my ARDS diagnosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 4 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determining improvement in pulmonary artery pressure in response to iNO
Determining improvement in right ventricular fractional area change in response to iNO
Determining improvement in tricuspid annular plane systolic excursion in response to iNO
Secondary study objectives
Improvement in serum creatinine in response to iNO
Improvement in urine output in response to iNO
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: iNOMAXExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide
2004
Completed Phase 4
~1280
Find a Location
Who is running the clinical trial?
Yuri MatusovLead Sponsor
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
15,846 Total Patients Enrolled
Yuri Matusov, MDPrincipal InvestigatorCedars-Sinai Medical Center