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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)

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ClinicalTrials.gov Identifier: NCT01993745
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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

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

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)

Study Type : Observational
Actual Enrollment : 106 participants
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)
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort
Study group
ECMO Patients survived
Control
ECMO Patient died



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01993745     History of Changes
Other Study ID Numbers: 200804046R
First Posted: November 25, 2013    Key Record Dates
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