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:
Collaborators:
Karolinska Institutet
Uppsala University Hospital
Information provided by (Responsible Party):
Bernhard Holzgraefe, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01763060
First received: January 4, 2013
Last updated: November 20, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763060

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

No publications provided

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
Study First Received: January 4, 2013
Last Updated: November 20, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
ards
ecmo
h1n1
pandemics

ClinicalTrials.gov processed this record on September 18, 2014