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
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Sponsor:
Medical University of Vienna
Information provided by:
Medical University of Vienna
Tracking Information | ||||
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First Submitted Date ICMJE | November 28, 2007 | |||
First Posted Date ICMJE | November 29, 2007 | |||
Last Update Posted Date | June 23, 2010 | |||
Study Start Date ICMJE | March 2005 | |||
Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
right ventricular size and arterial oxygenation [ Time Frame: 2 hours ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00565253 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
blood pressure, central venous pressure, right ventricular function, pulmonary artery pressure [ Time Frame: 2 hours ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Inhaled Nitric Oxide in Pulmonary Embolism | |||
Official Title ICMJE | Inhaled Nitric Oxide in Pulmonary Embolism, a Randomized, Double-Blind Placebo-Controlled Study | |||
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. | |||
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 ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Pulmonary Embolism | |||
Intervention ICMJE | Drug: Inhaled nitric oxide (NO)
20 ppm for 15 minutes |
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Study Arms | Not Provided | |||
Publications * | Capellier G, Jacques T, Balvay P, Blasco G, Belle E, Barale F. Inhaled nitric oxide in patients with pulmonary embolism. Intensive Care Med. 1997 Oct;23(10):1089-92. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | December 2009 | |||
Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00565253 | |||
Other Study ID Numbers ICMJE | 3052001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Medical University of Vienna | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Medical University of Vienna | |||
Verification Date | June 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |