Nitric Oxide to Treat Pulmonary Embolism

Indiana University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Pulmonary Embolism

Treatments: Drug: Sham; Drug: Inhaled Nitric Oxide

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01939301

1UM1HL113203-01A1 (U.S. NIH Grant/Contract)

Kline-1UM NO for PE

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

Inhaled Nitric Oxide

Active Comparator group

Description:

Inhaled nitric oxide

Treatment:

Drug: Inhaled Nitric Oxide

Placebo

Placebo Comparator group

Description:

Oxygen

Treatment:

Drug: Sham