Long Term Follow up of Patients Who Were Treated With Extracorporeal Membrane Oxygenation for Pandemic Influenza A/H1N1 Induced Severe Respiratory Failure

Long Term Outcome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763060
• Other study ID #: Dnr 2012/986-31/3
• Secondary ID: Long term outcom
• Status: Completed
• Phase: N/A
• First received: January 4, 2013
• Last updated: November 20, 2013
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

Patients treated with Extracorporeal Membrane Oxygenation (ecmo) for severe respiratory or circulatory failure show severe long term disability due to impaired lung -, cerebral-, cognitive function and impaired quality of life. This study investigates the long term outcome of all patients who are still alive three years after ECMO treatment for severe respiratory failure during the H1N1 2009 pandemic at the Karolinska University Hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Survivors of ECMO treatment for influenza a/h1n1 pneumonia during 2009/2010 pandemics at the ECMO Center Karolinska

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Long Term Outcome

Intervention

Radiation:
• CT scan

Behavioral:
• Cognitive function

Radiation:
• MRI

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function		3 years after ecmo treatment