Clinical trial NCT01939301: Nitric Oxide to Treat Pulmonary Embolism
Official title: Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Embolism
Keywords: Pulmonary embolism clot
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
name: National Institutes of Health (NIH)
name: University of Mississippi Medical Center
name: University of Texas, Southwestern Medical Center at Dallas
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-09-11
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Normal Right Ventricular (RV) Function and Viability
timeFrame: 5 days or hospital discharge (whichever occurs first)
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
Study officials:
affiliation: Indiana University
name: Jeff A Kline, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kline JA, Puskarich MA, Jones AE, Mastouri RA, Hall CL, Perkins A, Gundert EE, Lahm T. Inhaled nitric oxide to treat intermediate risk pulmonary embolism: A multicenter randomized controlled trial. Nitric Oxide. 2019 Mar 1;84:60-68. doi: 10.1016/j.niox.2019.01.006. Epub 2019 Jan 8.
citation: Kline JA, Hall CL, Jones AE, Puskarich MA, Mastouri RA, Lahm T. Randomized trial of inhaled nitric oxide to treat acute pulmonary embolism: The iNOPE trial. Am Heart J. 2017 Apr;186:100-110. doi: 10.1016/j.ahj.2017.01.011. Epub 2017 Jan 27.