NCT01089036

Brief Summary

We would like to investigate novel diagnostic methods or biomarkers to early predict the success of ECMO therapy for cardiogenic shock patients during the early stage after ECMO 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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

March 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2010

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 21, 2013

Status Verified

October 1, 2013

Enrollment Period

6.8 years

First QC Date

March 16, 2010

Last Update Submit

October 18, 2013

Conditions

Cardiogenic ShockAcute Myocardial InfarctionMyocarditisCardiomyopathy

Keywords

ECMOcardiogenic shockROSGPxcytokines

Outcome Measures

Primary Outcomes (1)

  • Mortality or multi-organ failure

    Patients who survived for more than 7 days after ECMO treatment were defined as survival, and non-survival patients were defined as expired or multiple organ failure incompatible with life within 7 days after ECMO installation.

    7 days

Study Arms (2)

survival

ECMO survival patients

ECMO non-survival

ECMO non-survivals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion criteria: 1. ≧ 18 yr. 2. cardiogenic shock, needing ECMO support Exclusion criteria 1. pre-existing sepsis 2. pre-existing chronic renal failure (dialysis dependent), liver failure, multiple organ failure

You may qualify if:

  • \. ≧ 18 yr. 2. cardiogenic shock, needing ECMO support

You may not qualify if:

  • \. pre-existing sepsis 2. pre-existing chronic renal failure (dialysis dependent), liver failure, multiple organ failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum,plasma, and cells for study. Once the study is completed, biospecimen will be discarded.

MeSH Terms

Conditions

Shock, CardiogenicMyocarditisCardiomyopathies

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Wen-Je Ko, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Je Ko, MD, PhD

CONTACT

0972651415kowj@ntu.edu.tw

Study Design

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

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 18, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 21, 2013

Record last verified: 2013-10

Locations

TW(2)