Nitric Oxide to Treat Pulmonary Embolism

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Terry Barclay, Indiana University
ClinicalTrials.gov Identifier:
NCT01939301
First received: August 28, 2013
Last updated: September 5, 2013
Last verified: September 2013
  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 (oxygen only) 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
Drug: Oxygen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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) ] [ Designated as safety issue: No ]
    RV function and viability assessed by the composite of normal RV size (<42 mm in diastole) and TAPSE > 16 mm and RIMP > 0.40(echocardiograph systolic measurements for RV) and serum hsTnT < 14pg/mL.


Estimated Enrollment: 78
Study Start Date: October 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Nitric Oxide
Inhaled nitric oxide
Drug: Nitric Oxide
Sham Comparator: Sham
oxygen
Drug: Oxygen

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >/= 18
  • CTPA - 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 by clinical care team to not use fibrinolytics or catheter or surgical embolectomy,
  • Plan to admit to a bed with telemetry capability

Exclusion Criteria:

  • Vasopressor support
  • 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

Contacts
Contact: Jeffrey A Kline, MD 317-287-3007 jefkline@iupui.edu
Contact: Terry A Barclay, RN 317-630-2543 tbarclay@iu.edu

Locations
United States, Indiana
Methodist Hospital Not yet recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Jeff A Kline, MD         
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Jeff A Kline, MD Indiana University
  More Information

No publications provided

Responsible Party: Terry Barclay, Research Project Manager, Indiana University
ClinicalTrials.gov Identifier: NCT01939301     History of Changes
Other Study ID Numbers: Kline-1UM NO for PE, 1UM1HL113203-01A1
Study First Received: August 28, 2013
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Indiana University:
Pulmonary embolism clot

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

ClinicalTrials.gov processed this record on August 28, 2014