Nitric Oxide to Treat Pulmonary Embolism

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Inhaled Nitric Oxide

Inhaled nitric oxide

Group Type ACTIVE_COMPARATOR

Inhaled Nitric Oxide

Intervention Type DRUG

Nitric Oxide + oxygen

Placebo

Oxygen

Group Type PLACEBO_COMPARATOR

Sham

Intervention Type DRUG

Nitrogen + Oxygen

Interventions

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Inhaled Nitric Oxide

Nitric Oxide + oxygen

Intervention Type DRUG

Sham

Nitrogen + Oxygen

Intervention Type DRUG

Other Intervention Names

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placebo oxygen

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No