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Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock

This study is currently recruiting participants.
Verified September 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01685112
First received: September 11, 2012
Last updated: October 10, 2012
Last verified: September 2012
History of Changes
  Purpose

Although few cases reported successful treatment of septic shock using extracorporeal membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a randomized study to allocate patients in such critical condition, we aimed to conduct a retrospective observational study using propensity score matched analysis to compare the survival of adults with septic shock treated by ECMO or conventional treatment.


Condition
Septic Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • In hospital mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    inhospital mortality as primary outcome, mean length of hospital stay around 30 days


Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Conventional Group
Patients who developed refractory shock, but didn't received ECMO as salvage treatment
ECMO group
Patient who have septic shock, and progreseed to have ECMO as salvage therapy

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults patient who admitted to ICU and had severe sepsis and progressed to septic shock

Criteria

Inclusion Criteria:

  • age >20
  • admitted at ICU
  • septic shock

Exclusion Criteria:

  • nil
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685112

Contacts
Contact: YuChung Chuang, MD 886-972652532 weischuang@gmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: YuChung Chuang, MD     886-972652532     weischuang@gmail.com    
Principal Investigator: YuChung Chuang, MD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: YuChung Chuang, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01685112     History of Changes
Other Study ID Numbers: 201207079RIC
Study First Received: September 11, 2012
Last Updated: October 10, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
adults
ECMO

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
 Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on June 18, 2013