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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01993745
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
The study is to show the prognostic factor of HRV parameter and cardiac fibrosis markers in critical illness patients

Condition
Cardiogenic Shock, With ECMO or IABP Support, With APACH II Score >25)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Heart Rate Variability and serum cardiac fibrosis markers in critical illness patients [ Time Frame: 2-4weeks ]
    1. 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

    2. List the primary condition or disease being studied Shock needing ECMO support


Enrollment: 106
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study group
ECMO Patients survived
Control
ECMO Patient died

Detailed 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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
adult age>18 years old
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993745


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01993745     History of Changes
Other Study ID Numbers: 200804046R
First Submitted: October 29, 2013
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by National Taiwan University Hospital:
ECMO
APACH II score

Additional relevant MeSH terms:
Shock
Critical Illness
Shock, Cardiogenic
Pathologic Processes
Disease Attributes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases