NCT02099279

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

March 23, 2014

Last Update Submit

August 31, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • duration of mechanical ventilation

    from ICU admission to extubation, an expected average of 8 days

Study Arms (1)

echocardiography examination

Device: echocardiography examination

Interventions

patients underwent echocardiography examination

echocardiography examination

Eligibility Criteria

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

All patients meeting the diagnostic criteria of AECOPD and admitted to ICU are potentially eligible for the present study. The diagnosis of AECOPD is based on that defined in Global Initiative for Chronic Obstructive Pulmonary Disease. AECOPD is defined using definitive criteria with at least two of the following major symptoms: increased dyspnea, increased sputum purulence, increased sputum volume; or one major and one minor symptom: nasal discharge/congestion, wheeze, sore throat and cough for at least two consecutive days.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinhua municipal central hospital

Jinhua, Zhejiang, 321000, China

Location

Related Publications (1)

  • Zhang Z, Chen L, Chen K, Ni H. The prognostic value of cardiac dysfunction assessed by bedside echocardiography in critically ill patients with COPD requiring mechanical ventilation: a study protocol. BMJ Open. 2014 Sep 25;4(9):e005359. doi: 10.1136/bmjopen-2014-005359.

Study Officials

  • Chen Kun, MB

    Jinhua Municipal Central Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
intensivist

Study Record Dates

First Submitted

March 23, 2014

First Posted

March 28, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

September 1, 2015

Record last verified: 2014-03

Locations