- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00565253
Inhaled Nitric Oxide in Pulmonary Embolism
June 22, 2010 updated by: Medical University of Vienna
Inhaled Nitric Oxide in Pulmonary Embolism, a Randomized, Double-Blind Placebo-Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Vienna, Austria, 1090
- University of Emergency Medicine, Medical University of Vienna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
right ventricular size and arterial oxygenation
Time Frame: 2 hours
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood pressure, central venous pressure, right ventricular function, pulmonary artery pressure
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Schenk, Prof MD MSc, Dpt. of Internal Medicine III, Medical University Vienna, Austria
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
November 28, 2007
First Submitted That Met QC Criteria
November 28, 2007
First Posted (Estimate)
November 29, 2007
Study Record Updates
Last Update Posted (Estimate)
June 23, 2010
Last Update Submitted That Met QC Criteria
June 22, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Embolism
- Pulmonary Embolism
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
Other Study ID Numbers
- 3052001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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