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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01993745
Other study ID # 200804046R
Secondary ID
Status Completed
Phase N/A
First received October 29, 2013
Last updated November 20, 2013
Start date May 2008
Est. completion date December 2009

Study information

Verified date November 2013
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

The study is to show the prognostic factor of HRV parameter and cardiac fibrosis markers in critical illness patients


Description:

The analysis of Heart Rate Variability with 24hrs Holter ECG and serum cardiac fibrosis markers in critical illness patients who are with cardiogenic shock, with ECMO or IABP support, or with APACH II score >25)


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date December 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- critical illness patients who are with cardiogenic shock, with ECMO or IABP support, or with APACH II score >25)

Exclusion Criteria:

- pacemaker rhythm, not sign the permit

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heart Rate Variability and serum cardiac fibrosis markers in critical illness patients Outcome measurement:
The measure is a composite outcome measure consisting of multiple measures (results to be reported as a single value for each Arm/Group), no changes are required
List the primary condition or disease being studied Shock needing ECMO support
2-4weeks No