Nitric Oxide to Treat Pulmonary Embolism

Phase 2

Completed

• Conditions: Pulmonary Embolism
• Interventions: Drug: Sham; Drug: Inhaled Nitric Oxide

• Registration Number: NCT01939301
• Lead Sponsor: Indiana University School of Medicine

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.

Study Timeline

• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-11
• Study Start: 2013-10
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Results First Submitted: 2018-01-23
• Results First Submitted QC: 2018-03-01
• Results First Posted: 2018-03-29
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Sham	Oxygen
Inhaled Nitric Oxide	Inhaled Nitric Oxide	Inhaled nitric oxide

Primary Outcome Measures

Name	Time	Method
Number of Participants With Normal Right Ventricular (RV) Function and Viability	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.

Trial Locations

Locations (4)

University of Mississippi; 🇺🇸 Jackson, Mississippi, United States

Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Eskenazi Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States