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

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. Identifier: NCT01763060
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : November 21, 2013
Karolinska Institutet
Uppsala University Hospital
Information provided by (Responsible Party):
Bernhard Holzgraefe, Karolinska University Hospital

Brief 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.

Condition or disease Intervention/treatment
Long Term Outcome Radiation: CT scan Behavioral: Cognitive function Radiation: MRI

Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Group/Cohort Intervention/treatment
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

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

Exclusion Criteria:

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 identifier (NCT number): NCT01763060

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

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

Keywords provided by Bernhard Holzgraefe, Karolinska University Hospital: