- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02972775
15-year Mortality After Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease (MORTCOP)
June 2, 2020 updated by: Pauline van Hirtum, Zuyderland Medisch Centrum
The investigators examine the 15-year mortality after an admission for an exacerbation of Chronic Obstructive Pulmonary disease (COPD).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Several prognostic factors will be examined.
Cause of death will be examined.
Data will be recruited from medical records and calling general practitioners to find out if a patient is still alive.
Statistical analysis will be done with Kaplan Meier, Cox proportional hazards and Chi square
Study Type
Observational
Enrollment (Actual)
845
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Heerlen, Limburg, Netherlands, 6419 PC
- Zuyderland Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted with an exacerbation of Chronic obstructive pulmonary disease in the Zuyderland medical Centre from 1996 - 1999
Description
Inclusion Criteria:
- admission with exacerbation of COPD
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of patients that died after 15 years
Time Frame: 15 years
|
Mortality after 15 years
|
15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prognostic factors for mortality
Time Frame: 15 years
|
Age (years), Gender (M / F), Previous hospitalization in the past year (yes/no), Re-admission in the next 5 years (number of readmissions per year), forced expiratory volume in 1 second (in liter), Hypercapnia (carbon dioxide in arterial blood in stable condition above 5.9 kiloPascal (kPa) or not), TLCO (transfusion capacity of the lung for carbon monoxide in percentage of predicted, ml / min / kPa), Comorbidity (Charlson Comorbidity Index) Date and cause of death
|
15 years
|
|
Cause of death
Time Frame: 15 years
|
Chronic obstructive pulmonary disease, lung carcinoma, cardiovascular, other
|
15 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martijn de Kruif, MD, PhD, Zuyderland Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
- Traver GA, Cline MG, Burrows B. Predictors of mortality in chronic obstructive pulmonary disease. A 15-year follow-up study. Am Rev Respir Dis. 1979 Jun;119(6):895-902. doi: 10.1164/arrd.1979.119.6.895.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2005
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
October 24, 2016
First Submitted That Met QC Criteria
November 20, 2016
First Posted (Estimate)
November 23, 2016
Study Record Updates
Last Update Posted (Actual)
June 4, 2020
Last Update Submitted That Met QC Criteria
June 2, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16N164
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.