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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02099279
Other study ID # echo_COPD
Secondary ID echo and COPD
Status Completed
Phase N/A
First received March 23, 2014
Last updated August 31, 2015
Start date January 2014
Est. completion date February 2015

Study information

Verified date March 2014
Source Jinhua Central Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

Chronic obstructive lung disease (COPD) is a major cause of morbidity and mortality, and is a major reason for ICU admission. Cardiac function is often impaired in this disease but its association with clinical outcome has not been fully established. The study aims to investigate the association between cardiac dysfunction and clinclial outcomes.


Description:

This is a prospective observational study conducted in a 47-bed mixed ICU of tertiary academic teaching hospital. The study will be performed between January 2014 to December 2015. All patients meeting the diagnostic criteria of AECOPD and admitted to ICU are potentially eligible for the present study. Relevant demographics and laboratory measurements are obtained. Transthoracic echocardiography (TTE) is performed immediately after ICU admission by experienced intensivists. Cox proportional hazard regression model is fitted by using stepwise forward selection and backward elimination technique. If linear assumption is not satisfied, the linear spline function will be used.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date February 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- COPD patients experiencing episode of exacerbation and require mechanical ventilation were admitted to ICU

Exclusion Criteria:

- COPD patients admitted to ICU due to other reasons (major surgery, ischemic heart disease, and renal failure)

- moribund and expected to die within 48 hours

- with Do-Not-Resuscitation order

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
echocardiography examination
patients underwent echocardiography examination

Locations

Country Name City State
China Jinhua municipal central hospital Jinhua Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Jinhua Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 28-day mortality 28 days after ICU admission; if a patient leave ICU before 28-days, it is considered as censored. 28 days after ICU admission No
Secondary duration of mechanical ventilation from ICU admission to extubation, an expected average of 8 days No
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