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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763060
First Posted: January 8, 2013
Last Update Posted: November 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Karolinska Institutet
Uppsala University Hospital
Information provided by (Responsible Party):
Bernhard Holzgraefe, Karolinska University Hospital
  Purpose
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.

Condition Intervention
Long Term Outcome Radiation: CT scan Behavioral: Cognitive function Radiation: MRI

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional

Further study details as provided by Bernhard Holzgraefe, Karolinska University Hospital:

Primary Outcome Measures:
  • Lung function [ Time Frame: 3 years after ecmo treatment ]

Enrollment: 7
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ECMO survivors
CT scan of the chest of all ECMO survivors after 2009/2010 pandemics Tests for cognitive function MRI of the brain Lung function
Radiation: CT scan Behavioral: Cognitive function Radiation: MRI

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients who survived ECMO treatment due to infection with Influenza A/H1N1 2009 up to 3 years after discharge from hospital
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763060


Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Uppsala University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bernhard Holzgraefe, MD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01763060     History of Changes
Other Study ID Numbers: Dnr 2012/986-31/3
Long term outcome ( Other Identifier: Ehtical committee Stockholm )
First Submitted: January 4, 2013
First Posted: January 8, 2013
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Bernhard Holzgraefe, Karolinska University Hospital:
ards
ecmo
h1n1
pandemics