NCT02259439

Brief Summary

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) represent a leading cause of morbidity and mortality.Patients admitted to hospital present higher mortality rates.The investigators lack the specific tools that allow us to easily classify and establish the individual prognosis for each patient during their hospitalization. Rational of the study:to identify the predictive factors for hospital mortality in critically ill patients admitted to hospital due to an episode of COPD exacerbation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

October 1, 2014

Enrollment Period

3 years

First QC Date

September 17, 2014

Last Update Submit

March 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Calculate the mortality of exacerbated patients based on APACHE II and SOFA score, respiratory rate upon admittance, age, pO2/ FiO2 in the first few hours of admittance.

    Calculate mortality caused by AECOPD depend upon APACHE II and SOFA score

    24 hours

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We include for study all patients critically ill hospitalized for COPD exacerbation during the study period.

You may qualify if:

  • We include for study all patients critically ill hospitalized for COPD exacerbation during the study period

You may not qualify if:

  • Patients who refuse to be admitted to hospital after having been properly informed, and their families as well, of the possible risks that they are assuming.
  • Specific diagnosis: pulmonary edema, rib fractures, aspiration, pleural effusion, etc. upon admission.
  • Other associated respiratory pathology that determines treatment: pulmonary fibrosis, kyphoscoliosis, neuromuscular pathology, upper airway obstruction, extensive tuberculosis sequelae.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chest Department-faculty of medicine-Assuit university

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Nermeen Abdel Aleem

CONTACT

Mohamed Metwally

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chest department- faculity of medicine -Assiut university- Egypt

Study Record Dates

First Submitted

September 17, 2014

First Posted

October 8, 2014

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

April 1, 2015

Record last verified: 2014-10

Locations