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Completed

NCT Number: NCT01939301

Nitric Oxide to Treat Pulmonary Embolism

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eskenazi Hospital, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled Nitric Oxide

Drug

Nitric Oxide + oxygen

sham

Drug

Nitrogen + Oxygen

Other names: placebo, oxygen

Primary outcomes

  1. Number of Participants With Normal Right Ventricular (RV) Function and Viability

    Time frame: 5 days or hospital discharge (whichever occurs first)

    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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

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

Registry information

Official study title

Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2013
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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