Clinical Trial: Nitric Oxide to Treat Pulmonary Embolism
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
Brief Summary: This is a randomized, double blind study to treat subjects diagnosed with pulmonary embolism with inhaled nitrix oxide. In this clinical trial investigators will randomized patients to receive inhaled nitric oxide or sham (nitrogen + oxygen) for 24 hours. Patients must have a submassive pulmonary embolism (PE) and evidence of right ventricular (RV) heart dysfunction. Investigators hypothesize that the administration of inhaled NO + oxygen to patients with severe submassive PE will improve RV function, reduce RV strain and necrosis and improve dyspnea (difficulty breathing) more than sham oxygen treatment.
Detailed Summary:
Sponsor: Indiana University School of Medicine
Current Primary Outcome: RV function and viability [ Time Frame: 5 days or hospital discharge (whichever occurs first) ]
Original Primary Outcome: RV function and viability [ Time Frame: 5 days or hospital discharge (whichever occurs first) ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Indiana University
Dates:
Date Received: August 28, 2013
Date Started: October 2013
Date Completion: February 2018
Last Updated: March 30, 2017
Last Verified: March 2017