Pulmonary Embolism Clinical Trial
Official title:
Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
Verified date | September 2018 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).
Status | Completed |
Enrollment | 78 |
Est. completion date | October 31, 2016 |
Est. primary completion date | October 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Eskenazi Hospital | Indianapolis | Indiana |
United States | Indiana University Hospital | Indianapolis | Indiana |
United States | Methodist Hospital | Indianapolis | Indiana |
United States | University of Mississippi | Jackson | Mississippi |
Lead Sponsor | Collaborator |
---|---|
Indiana University School of Medicine | 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 |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Normal Right Ventricular (RV) Function and Viability | Right ventricular (RV) function and viability assessed by the composite of normal RV size (<42 mm in diastole) and tricuspid annular plane systolic excursion (TAPSE) > 16 mm and normal right ventricular index of myocardial performance (RIMP) < 0.40 using spectral Doppler or < 0.55 using tissue Doppler) and normal fractional area change (FAC) (> 33%) and a serum hsTnT < 14pg/mL. Missing values will be considered normal. | 5 days or hospital discharge (whichever occurs first) |
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