NCT01939301

Nitric Oxide to Treat Pulmonary Embolism

Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).

Detailed description

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.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Inhaled Nitric Oxide	Nitric Oxide + oxygen
DRUG	Sham	Nitrogen + Oxygen

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-10-31
• Completion: 2016-10-31
• First posted: 2013-09-11
• Last updated: 2018-10-03
• Results posted: 2018-03-29

Locations

4 sites across 1 country: United States