NCT01247727

Brief Summary

National Taiwan University Hospital is the leading center for care of patients with extracorporeal membrane oxygenation (ECMO). The predictable factors associated with outcomes are still lacking in patients with the ECMO support. The aim of this study is to collect the electrical signals stored in the monitor of intensive care units (ICUs), which are analyzed by the bio-informatics software. The pre-, peri-, and post-ECMO heart rate variability, including linear and non-linear analysis is calculated to address the association with outcomes of patients with ECMO. In addition, we collected the demographics, body temperature, respiratory rate, and blood pressure to investigate the causes of heart rate variability.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 22, 2011

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

November 22, 2010

Last Update Submit

April 21, 2011

Conditions

Keywords

Heart rate variabilityextracorporeal membrane oxygenation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with the support of extracorporeal membrane oxygenation

You may qualify if:

  • Adults patients (aged \> 18 years; less than 90 years old) used ECMO for cardiopulmonary support

You may not qualify if:

  • Patients used illicit drugs
  • Patients received heart transplantation
  • Patients have the history of arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

  • Wen-Je Ko, M.D., Ph.D.

    National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Jin-Ming Wu, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 24, 2010

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

April 22, 2011

Record last verified: 2011-03

Locations