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Inhaled Nitric Oxide in Pulmonary Embolism

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Inhaled nitric oxide (NO)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring pulmonary embolism, inhaled nitric oxide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Emergency Medicine, Medical University of Vienna

Outcomes

Primary Outcome Measures

right ventricular size and arterial oxygenation

Secondary Outcome Measures

blood pressure, central venous pressure, right ventricular function, pulmonary artery pressure

Full Information

First Posted
November 28, 2007
Last Updated
June 22, 2010
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00565253
Brief Title
Inhaled Nitric Oxide in Pulmonary Embolism
Official Title
Inhaled Nitric Oxide in Pulmonary Embolism, a Randomized, Double-Blind Placebo-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
pulmonary embolism, inhaled nitric oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Inhaled nitric oxide (NO)
Intervention Description
20 ppm for 15 minutes
Primary Outcome Measure Information:
Title
right ventricular size and arterial oxygenation
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
blood pressure, central venous pressure, right ventricular function, pulmonary artery pressure
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Schenk, Prof MD MSc
Organizational Affiliation
Dpt. of Internal Medicine III, Medical University Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Emergency Medicine, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
9407246
Citation
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. doi: 10.1007/s001340050461.
Results Reference
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Inhaled Nitric Oxide in Pulmonary Embolism

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