Nitric Oxide to Treat Pulmonary Embolism

September 6, 2018 updated by: Jeffrey Kline, Indiana University School of Medicine

Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hospital
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital
      • Indianapolis, Indiana, United States, 46202
        • Eskenazi Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 36216
        • University of Mississippi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Inhaled Nitric Oxide
Inhaled nitric oxide
Drug: Inhaled Nitric Oxide
Nitric Oxide + oxygen
PLACEBO_COMPARATOR: Placebo
Oxygen
Drug: Sham
Nitrogen + Oxygen
Other Names:
  • placebo
  • oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days or hospital discharge (whichever occurs first)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Mallinckrodt
University of Mississippi Medical Center
University of Texas, Southwestern Medical Center at Dallas

Investigators

  • Principal Investigator: Jeff A Kline, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

October 31, 2016

Study Completion (ACTUAL)

October 31, 2016

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (ESTIMATE)

September 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kline-1UM NO for PE
  • 1UM1HL113203-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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