NCT01993745

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

October 29, 2013

Last Update Submit

November 20, 2013

Conditions

Keywords

ECMOAPACH II score

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Variability and serum cardiac fibrosis markers in critical illness patients

    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

    2-4weeks

Study Arms (2)

Study group

ECMO Patients survived

Control

ECMO Patient died

Eligibility Criteria

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

adult age\>18 years old

You may qualify if:

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

You may not qualify if:

  • pacemaker rhythm, not sign the permit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 25, 2013

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

December 1, 2009

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations