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Inhaled Nitric Oxide in Pulmonary Embolism

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ClinicalTrials.gov Identifier: NCT00565253
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : June 23, 2010
Sponsor:
Information provided by:
Medical University of Vienna

Brief Summary:
The purpose of the study is to determine if inhaled nitric oxide, a potent and selective pulmonary vasodilator, is beneficial in patients with acute pulmonary embolism causing increased right ventricular afterload.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: Inhaled nitric oxide (NO) Phase 2

Detailed Description:
The early phase of severe pulmonary embolism is associated with high mortality. Right ventricular failure induced by the increase in right ventricular afterload is the final cause of deterioration leading to circulatory failure in patients who die from severe pulmonary embolism. Therefore, reduction of right ventricular afterload remains the central therapeutic strategy. In acute pulmonary embolism, the increase in pulmonary vascular resistance is caused by reduction in the cross-sectional area of the pulmonary vascular bed from obstructing emboli. Pulmonary arterial constriction further increases pulmonary vascular resistance, whereby vasoactive humoral factors may be contributing, which are released from activated platelets accumulating at the site of the clot. Consequently, administration of vasodilators of the pulmonary circulation may be regarded as a therapeutic option to antagonize increased pulmonary vasoconstriction or compensate for impaired vasodilation. Inhaled nitric oxide (NO) acts as a powerful selective pulmonary vasodilator. The aim of the study is to determine, if short-term inhalation of NO is beneficial in respiratory compromised patients with right ventricular dysfunction after acute pulmonary embolism.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inhaled Nitric Oxide in Pulmonary Embolism, a Randomized, Double-Blind Placebo-Controlled Study
Study Start Date : March 2005
Primary Completion Date : July 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Inhaled nitric oxide (NO)
    20 ppm for 15 minutes


Primary Outcome Measures :
  1. right ventricular size and arterial oxygenation [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. blood pressure, central venous pressure, right ventricular function, pulmonary artery pressure [ Time Frame: 2 hours ]


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:

  • Patients with acute pulmonary embolism within 24 hours after onset of symptoms.
  • Patients with hypoxaemia not present before pulmonary embolism and acute right ventricular dysfunction.

Exclusion Criteria:

  • Age < 18 years.
  • Chronic lung disease, left heart failure, suspected or documented intracranial bleeding.
  • Pregnancy, Methaemoglobinaemia.
  • Patients who previously needed thrombolysis or surgical embolectomy.
  • Negative D-Dimer test.

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): NCT00565253


Locations
Austria
University of Emergency Medicine, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Peter Schenk, Prof MD MSc Dpt. of Internal Medicine III, Medical University Vienna, Austria

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00565253     History of Changes
Other Study ID Numbers: 3052001
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: June 23, 2010
Last Verified: June 2010

Keywords provided by Medical University of Vienna:
pulmonary embolism
inhaled nitric oxide

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