Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Nitric Oxide to Treat Pulmonary Embolism

This study is ongoing, but not recruiting participants.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01939301
First received: August 28, 2013
Last updated: March 30, 2017
Last verified: March 2017
  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: 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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 ( US NIH Grant/Contract Award Number )
Study First Received: August 28, 2013
Last Updated: March 30, 2017

Keywords provided by 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

ClinicalTrials.gov processed this record on April 28, 2017