Phase 2
N=78
Nitric Oxide to Treat Pulmonary Embolism
Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT01939301 ↗Enrolled (actual)
78
Serious AEs
5.3%
Results posted
Mar 2018
Primary outcome: Primary: Number of Participants With Normal Right Ventricular (RV) Function and Viability — 9; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Inhaled Nitric Oxide (Drug); Sham (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Normal Right Ventricular (RV) Function and Viability |
9; 5 | — |
Summary
This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).
Eligibility Criteria
Inclusion Criteria
- 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
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
Data sourced from ClinicalTrials.gov (NCT01939301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.