Nitric Oxide to Treat Pulmonary Embolism

• Status: Completed
• Trial end date: 2016-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University School of Medicine
• Collaborators: Mallinckrodt; National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH); University of Mississippi Medical Center; University of Texas, Southwestern Medical Center at Dallas
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Age >/= 18

• Pulmonary imaging-proven PE, as interpreted by local radiologist

• At least one predictor of RV dysfunction:

1. echocardiography with RV dilation or hypokinesis,

2. estimated RVSP >40mm HG,

3. RV>LV on CTPA,

4. elevated troponin I (>0.1 ng/mL) or natriuretic peptide (BNP > 90 pg/mL),

5. screening bedside cardiac ultrasound with color flow capability that shows RV dysfunction,

6. RV strain on ECG

• Plan to admit to a bed with telemetry capability

Exclusion Criteria:

• 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