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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02972775
Other study ID # 16N164
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2005
Est. completion date October 2017

Study information

Verified date June 2020
Source Zuyderland Medisch Centrum
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators examine the 15-year mortality after an admission for an exacerbation of Chronic Obstructive Pulmonary disease (COPD).


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


Recruitment information / eligibility

Status Completed
Enrollment 845
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- admission with exacerbation of COPD

Exclusion Criteria:

- none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no interventions. observational study


Locations

Country Name City State
Netherlands Zuyderland Medical Center Heerlen Limburg

Sponsors (1)

Lead Sponsor Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

Vestbo J, Hurd SS, Agustí 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients that died after 15 years Mortality after 15 years 15 years
Secondary Prognostic factors for mortality 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
Secondary Cause of death Chronic obstructive pulmonary disease, lung carcinoma, cardiovascular, other 15 years
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