NCT01763060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

January 4, 2013

Last Update Submit

November 20, 2013

Conditions

Long Term Outcome

Keywords

ardsecmoh1n1pandemics

Outcome Measures

Primary Outcomes (1)

  • Lung function

    3 years after ecmo treatment

Study Arms (1)

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 scanBehavioral: Cognitive functionRadiation: MRI

Interventions

CT scanRADIATION
ECMO survivors
Cognitive functionBEHAVIORAL
ECMO survivors
MRIRADIATION
ECMO survivors

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • Holzgraefe B, Andersson C, Kalzen H, von Bahr V, Mosskin M, Larsson EM, Palmer K, Frenckner B, Larsson A. Does permissive hypoxaemia during extracorporeal membrane oxygenation cause long-term neurological impairment?: A study in patients with H1N1-induced severe respiratory failure. Eur J Anaesthesiol. 2017 Feb;34(2):98-103. doi: 10.1097/EJA.0000000000000544.

    PMID: 28030441DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 8, 2013

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

SE(1)