Nitric Oxide to Treat Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939301
• Other study ID #: Kline-1UM NO for PE
• Secondary ID: 1UM1HL113203-01A
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Est. completion date: October 31, 2016

Study information

• Verified date: September 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• Inhaled Nitric Oxide
Nitric Oxide + oxygen
• Sham
Nitrogen + Oxygen

Locations

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

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

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)