Inhaled Nitric Oxide in Pulmonary Embolism
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pulmonary Embolism |
Drug: Inhaled nitric oxide (NO) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Inhaled Nitric Oxide in Pulmonary Embolism, a Randomized, Double-Blind Placebo-Controlled Study |
- right ventricular size and arterial oxygenation [ Time Frame: 2 hours ]
- blood pressure, central venous pressure, right ventricular function, pulmonary artery pressure [ Time Frame: 2 hours ]
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2005 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
-
Drug: Inhaled nitric oxide (NO)
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Austria | |
| University of Emergency Medicine, Medical University of Vienna | |
| Vienna, Austria, 1090 | |
| Principal Investigator: | Peter Schenk, Prof MD MSc | Dpt. of Internal Medicine III, Medical University Vienna, Austria |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00565253 History of Changes |
| Other Study ID Numbers: | 3052001 |
| Study First Received: | November 28, 2007 |
| Last Updated: | June 22, 2010 |
| Health Authority: | Austria: Agency for Health and Food Safety |
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 |
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 Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013