Comparison of ECMO Use and Conventional Treatment in Adul... | NCT01685112

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

NCT01685112

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Oct 12, 2012Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Septic Shock

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Aug 2013Estimated

Completion Date

Aug 2013Estimated

First Submitted Date

Sep 11, 2012

First Submission Date that Met QC Criteria

Sep 12, 2012

First Posted Date

Sep 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2012

Last Update Posted Date

Oct 12, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In hospital mortality	inhospital mortality as primary outcome, mean length of hospital stay around 30 days	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >20
admitted at ICU
septic shock

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YuChung Chuang, MD	Contact	886-972652532		weischuang@gmail.com

Overall Officials

Name	Affiliation	Role
YuChung Chuang, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei	Taiwan	100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided