Inhaled Nitric Oxide in Pulmonary Embolism

This study has been completed.

Sponsor:

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00565253

First received: November 28, 2007

Last updated: June 22, 2010

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 28, 2007

Last Updated Date

June 22, 2010

Start Date ^ICMJE

March 2005

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: Double Blind (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

Completion Date

December 2009

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

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

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

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

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