Nitric Oxide to Treat Pulmonary Embolism

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Embolism

In brief

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

Key facts

Study ID

NCT01939301

Run by

Indiana University

People needed

78

Starts

2013-10-01

Expected to finish

2016-10-31

Last updated by the study team

2018-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >/= 18
• Pulmonary imaging-proven PE, as interpreted by local radiologist
• At least one predictor of RV dysfunction:
• echocardiography with RV dilation or hypokinesis,
• estimated RVSP >40mm HG,
• RV>LV on CTPA,
• elevated troponin I (>0.1 ng/mL) or natriuretic peptide (BNP > 90 pg/mL),
• screening bedside cardiac ultrasound with color flow capability that shows RV dysfunction,
• RV strain on ECG
• Plan to admit to a bed with telemetry capability

You may not qualify if…

• Vasopressor support at time of enrollment
• Pregnancy
• Plan by clinical care team to use lytic or surgical embolectomy
• Plan by clinical team to use platelet inhibiting drugs
• Contraindication to anticoagulation
• Altered mental status such that the patient is unable to provide informed consent
• Inability to use a nasal cannula or face mask
• Comfort care measures instituted
• Supplemental oxygen requirements greater than can be administered via nasal cannula in order to maintain Sa)2 > 80%
• Pneumothorax with decompression
• Serum MetHb > 10%
• Recent use of drugs known to increase cGMP
• Use of nitroprusside or nitroglycerin within the last 4 hours
• Use of any other nitrates with in the past 24 hours
• Use of a fibrinolytic medicine within the past 14 days

Where it is running

• Eskenazi Hospital — Indianapolis, Indiana, United States
• Indiana University Hospital — Indianapolis, Indiana, United States
• Methodist Hospital — Indianapolis, Indiana, United States
• University of Mississippi — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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