Inhaled Nitric Oxide in Pulmonary Embolism

Phase 2

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT00565253
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2007-11-28
• Study First Submitted QC: 2007-11-28
• Study First Posted: 2007-11-29
• Primary Completion: 2009-07
• Study Completion: 2009-12
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-22
• Last Update Posted: 2010-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
right ventricular size and arterial oxygenation	2 hours

Secondary Outcome Measures

Name	Time	Method
blood pressure, central venous pressure, right ventricular function, pulmonary artery pressure	2 hours

Trial Locations

Locations (1)

University of Emergency Medicine, Medical University of Vienna; 🇦🇹 Vienna, Austria