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NCT01468142 Clinical Trial

Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure

Respiratory Distress Syndrome, Adult Clinical Trial

Official title:
Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01468142
Other study ID # 2011/1282-31/1
Secondary ID
Status Completed
Phase N/A
First received November 7, 2011
Last updated December 19, 2016
Start date February 2012
Est. completion date December 2016

Study information
Verified date December 2016
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is the observation of the course of

- the mechanics of the respiratory system

- the endexpiratory lung volume

- and the inflammatory response in patients undergoing treatment with extracorporeal life support (ECLS) due to severe refractory respiratory failure at our department.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 3 Years and older
Eligibility Inclusion Criteria:

- patients accepted for extracorporeal life support at our department due to the most severe forms of ARDS/respiratory failure not responding to conventional therapy.

Exclusion Criteria:

- malignant disease with a poor prognosis

- massive intracranial bleeding

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden ECMO Centre Karolinska Solna Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Course of inflammatory parameters and lung function end of treatment No
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