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Nitric Oxide to Treat Pulmonary Embolism

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01939301
First Posted: September 11, 2013
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mallinckrodt
National Institutes of Health (NIH)
University of Mississippi Medical Center
University of Texas, Southwestern Medical Center at Dallas
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey Kline, Indiana University
  Purpose
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.

Condition Intervention Phase
Pulmonary Embolism Drug: Nitric Oxide + oxygen Drug: Nitrogen + Oxygen Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by Jeffrey Kline, Indiana University:

Primary Outcome Measures:
  • RV function and viability [ Time Frame: 5 days or hospital discharge (whichever occurs first) ]
    RV function and viability assessed by the composite of normal RV size (<42 mm in diastole) and TAPSE > 16 mm and normal RIMP < 0.40 using spectral Doppler or < 0.55 using tissue Doppler) and normal FAC (> 33%) and a serum hsTnT < 14pg/mL. Missing values will be considered normal.


Enrollment: 78
Study Start Date: October 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Nitric Oxide
Inhaled nitric oxide
Drug: Nitric Oxide + oxygen
Sham Comparator: Sham
oxygen
Drug: Nitrogen + Oxygen

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939301


Locations
United States, Indiana
Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Methodist Hospital
Indianapolis, Indiana, United States, 46202
United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 36216
Sponsors and Collaborators
Indiana University School of Medicine
Mallinckrodt
National Institutes of Health (NIH)
University of Mississippi Medical Center
University of Texas, Southwestern Medical Center at Dallas
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jeff A Kline, MD Indiana University
  More Information

Responsible Party: Jeffrey Kline, Vice Chair of Research, Indiana University
ClinicalTrials.gov Identifier: NCT01939301     History of Changes
Other Study ID Numbers: Kline-1UM NO for PE
1UM1HL113203-01A1 ( U.S. NIH Grant/Contract )
First Submitted: August 28, 2013
First Posted: September 11, 2013
Last Update Posted: March 31, 2017
Last Verified: March 2017

Keywords provided by Jeffrey Kline, Indiana University:
Pulmonary embolism clot

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents