Inhaled Nitric Oxide in Pulmonary Embolism

Tracking Information
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; (submitted: November 28, 2007)	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; (submitted: November 28, 2007)	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
Condition ICMJE	Pulmonary Embolism
Intervention ICMJE	Drug: Inhaled nitric oxide (NO); 20 ppm for 15 minutes
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: November 28, 2007)	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: 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.
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Peter Schenk, Prof MD MSc Dpt. of Internal Medicine III, Medical University Vienna, Austria
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