Chronic Obstructive Pulmonary DiseaseNCT02259439
Assessment of Updated Evaluation Scores in Critically ILL COPD Patients Admitted to Assiut University Hospital
An observational study of Chronic Obstructive Pulmonary Disease, run by Nermeen Aly Mahmoud Abdel Aleem at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We include for study all patients critically ill hospitalized for COPD exacerbation during the study period.
Who may be able to join
- We include for study all patients critically ill hospitalized for COPD exacerbation during the study period
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Chest Department-faculty of medicine-Assuit university
Asyut
About this study
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.
Read the detailed description
Material and Methods:
- sociodemographic variables:
Age, sex, marital status, occupation, pack\year.
- clinical variables:
1- Dyspnea measured by the Medical Research Council (MRC) scale and the COPD Assessment Test (CAT ) while stable, previous to admittance.
3- Charlson comorbidity index and age adjusted model.
4- The APACHE II scale: the severity of the episode upon admittance, calculated using the APACHE II scale, using the worst value obtained in the first 24h after being admitted to hospital.
5- the Sequential Organ Failure Assessment (SOFA) scale.
6- Lab parameters: such as glucose, albumin and heamatocrit
7- BAP-65 score: elevated blood urea nitrogen, altered mental status, pulse > 109 beats/min, age > 65 years.
8- Assessment of symptom of gastroesophageal reflux disease.
9-Glasgow scale score.
10-CURB 65 :"C" stands for "confused"; "U" stands for BUN greater than19 mg/dL; "R" stands for "respiration more than 30 breaths per minute""B" stands for blood pressure less than 90 mm Hg systolic or diastolic blood pressure 60 mm Hg or less; "65" stands ≥65 years.
11-CAUDA 70: C: Confusion, Acidosis (pH <7.35), Urea >7mmol/L, MRC Dyspnoea score >4, Albumin <35g/L, Age >70 years. One point was assigned to each variable present, giving a six point scoring system.
12-The COPD and Asthma Physiology Score.
13-The early warning score.
14-ADO index: comprised of age, dyspnea by the MRC, and FEV1. Scores ranged from 0 (best status) to 5 (worst status) for age, 0-3 for MRC, and 0-2 for FEV1. Points for each component were added so that the ADO index ranged from 0 to 10.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startSep 2012
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nermeen Aly Mahmoud Abdel Aleem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nermeen Aly Mahmoud Abdel Aleem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259439
- Sponsor's protocol ID
- 16022012
- Status last verified
- Oct 2014
- First submitted
- 17 Sep 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Updated Evaluation Scores in Critically ILL COPD Patients Admitted to Assiut University Hospital
- ClinicalTrials.gov ID
- NCT02259439
- Acronym / sponsor ID
- 16022012
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nermeen Aly Mahmoud Abdel AleemUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Material and Methods:
- sociodemographic variables:
Age, sex, marital status, occupation, pack\year.
- clinical variables:
1- Dyspnea measured by the Medical Research Council (MRC) scale and the COPD Assessment Test (CAT ) while stable, previous to admittance.
3- Charlson comorbidity index and age adjusted model.
4- The APACHE II scale: the severity of the episode upon admittance, calculated using the APACHE II scale, using the worst value obtained in the first 24h after being admitted to hospital.
5- the Sequential Organ Failure Assessment (SOFA) scale.
6- Lab parameters: such as glucose, albumin and heamatocrit
7- BAP-65 score: elevated blood urea nitrogen, altered mental status, pulse > 109 beats/min, age > 65 years.
8- Assessment of symptom of gastroesophageal reflux disease.
9-Glasgow scale score.
10-CURB 65 :"C" stands for "confused"; "U" stands for BUN greater than19 mg/dL; "R" stands for "respiration more than 30 breaths per minute""B" stands for blood pressure less than 90 mm Hg systolic or diastolic blood pressure 60 mm Hg or less; "65" stands ≥65 years.
11-CAUDA 70: C: Confusion, Acidosis (pH <7.35), Urea >7mmol/L, MRC Dyspnoea score >4, Albumin <35g/L, Age >70 years. One point was assigned to each variable present, giving a six point scoring system.
12-The COPD and Asthma Physiology Score.
13-The early warning score.
14-ADO index: comprised of age, dyspnea by the MRC, and FEV1. Scores ranged from 0 (best status) to 5 (worst status) for age, 0-3 for MRC, and 0-2 for FEV1. Points for each component were added so that the ADO index ranged from 0 to 10.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We include for study all patients critically ill hospitalized for COPD exacerbation during the study period.
Key inclusion criteria (1 listed)
- We include for study all patients critically ill hospitalized for COPD exacerbation during the study period
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 24 hours
Calculate mortality caused by AECOPD depend upon APACHE II and SOFA score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Nermeen Aly Mahmoud Abdel Aleem at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nermeen Abdel Aleem (01007174772, nermeenabdelaleem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.