NCT01685112

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 12, 2012

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

September 11, 2012

Last Update Submit

October 10, 2012

Conditions

Septic Shock

Keywords

adultsECMO

Outcome Measures

Primary Outcomes (1)

  • In hospital mortality

    inhospital mortality as primary outcome, mean length of hospital stay around 30 days

    30 days

Study Arms (2)

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 Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • age \>20
  • admitted at ICU
  • septic shock

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • YuChung Chuang, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YuChung Chuang, MD

CONTACT

886-972652532weischuang@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 13, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 12, 2012

Record last verified: 2012-09

Locations

TW(1)