COPD ExacerbationNCT05370664
Performance of Novel Bed Side Scores as Predictors of Hospital Outcome in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Among Women; Cohort Study
An observational study of COPD Exacerbation, run by Assiut University.
Trial summary
Assess predictors of mortality in COPD exacerbation between men and women. Evaluate the clinical outcomes in acute exacerbation of COPD in women. Evaluate the validity of new scoring systems ( NIVO, DECAF, HACOR ) as a predictor for hospital outcome in acute exacerbation of COPD. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- COPD Exacerbation
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Apr 2025
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled in the study will be subjected to the following: A- Careful History Taking and clinical examination. B- Laboratory investigations which include : I. Complete blood count. II. Arterial blood gas. III. Liver \& kidney function tests. IV. Blood sugar level \& serum electrolytes. V. Serum granulocyte colony-stimulating factor ( GM-CSF) C- Severity of illness assessed by: I. NIVO Score ( Non-invasive outcomes score ) II. DECAF Score III. HACOR Score IV. ( Acute physiology and chronic health evaluation ) APACHE IV Score. 200 patients (100 females, 100 males) with acute exacerbation of COPD will be admitted to the RICU will be observed as regards temperature, blood pressure, respiratory rate, pulse, oxygen saturation, and arterial blood gas will be obtained on NIV. colony-stimulating factor will also be assessed on the first day of admission and after weaning from NIV.
Who may be able to join
- Patients with AECOPD leading to hypoxemia, hypercapnia and respiratory acidosis with pH < 7.35 and PaCO2 > 45 mm of Hg will be admitted to the respiratory intensive care unit (ICU) for NIV or the ward will be eligible for inclusion and not in need for mechanical ventilation
Who cannot join
- Requirement for emergency intubation.
- Other contraindications to NIPPV including cardiac or respiratory arrest; nonrespiratory organ failure (eg, severe encephalopathy, severe gastrointestinal bleeding, hemodynamic instability with or without unstable cardiac angina); facial surgery or trauma; upper-airway obstruction; inability to protect the airway and/or high risk of aspiration; and inability to clear secretions.(6)
- Age < 35 years.
Trial locations and contacts
No sites are listed yet.
About this study
- Assess predictors of mortality in COPD exacerbation between men and women.
- Evaluate the clinical outcomes in acute exacerbation of COPD in women.
- Evaluate the validity of new scoring systems ( NIVO, DECAF, HACOR ) as a predictor for hospital outcome in acute exacerbation of COPD.
- Compare these new scoring system with the most widely used APACHE IV.
- Assessment of serum level of granulocyte colony stimulating factor ( GM-CSF) in detecting the severity of COPD exacerbation.
- Conditions
- COPD Exacerbation
- Keywords
- NIVO, DECAF, HACOR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female COPD | Not described | |
| Male COPD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate among COPD patients hospitalized due to acute exacerbation.
Assessment of mortality with different scoring systems in acute exacerbation of COPD
Measured: 28 days from admissiom
Early prediction of NIV failure.
Using NIVO score for Acute exacerbaion of COPD Non-invasive ventilation outcomes score is considered to be Low risk ( 0-2) Moderate risk (3-4) High risk (5-6) Very high risk ( 7-9)
Measured: 48 hours from ICU admission
Assessment of GM-CSF as a biomarker for successful therapy in acute exacerbation of COPD.
Assessment of granulocyte colony stimulating factor by ELISA test in acute exacerbation of COPD
Measured: baseline
Secondary outcomes (1)
Assisted ventilation days.
Estimating the number of days required for either non-invasive or invasive mechanical ventilation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Essmat Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370664
- Sponsor's protocol ID
- Mortality outcome in COPD
- Status last verified
- Jun 2022
- First submitted
- 7 May 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Halpin DMG, Criner GJ, Papi A, Singh D, Anzueto A, Martinez FJ, Agusti AA, Vogelmeier CF. Global Initiative for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease. The 2020 GOLD Science Committee Report on COVID-19 and Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2021 Jan 1;203(1):24-36. doi: 10.1164/rccm.202009-3533SO.
PubMed 33146552Chakrabarti A, Mar JS, Choy DF, Cao Y, Rathore N, Yang X, Tew GW, Li O, Woodruff PG, Brightling CE, Grimbaldeston M, Christenson SA, Bafadhel M, Rosenberger CM. High serum granulocyte-colony stimulating factor characterises neutrophilic COPD exacerbations associated with dysbiosis. ERJ Open Res. 2021 Aug 2;7(3):00836-2020. doi: 10.1183/23120541.00836-2020. eCollection 2021 Jul.
PubMed 34350278Jenkins CR, Chapman KR, Donohue JF, Roche N, Tsiligianni I, Han MK. Improving the Management of COPD in Women. Chest. 2017 Mar;151(3):686-696. doi: 10.1016/j.chest.2016.10.031. Epub 2016 Nov 2.
PubMed 27816445Duan J, Wang S, Liu P, Han X, Tian Y, Gao F, Zhou J, Mou J, Qin Q, Yu J, Bai L, Zhou L, Zhang R. Early prediction of noninvasive ventilation failure in COPD patients: derivation, internal validation, and external validation of a simple risk score. Ann Intensive Care. 2019 Sep 30;9(1):108. doi: 10.1186/s13613-019-0585-9.
PubMed 31565779Hartley T, Lane ND, Steer J, Elliott MW, Sovani MP, Curtis HJ, Fuller ER, Murphy PB, Shrikrishna D, Lewis KE, Ward NR, Turnbull CD, Hart N, Bourke SC. The Noninvasive Ventilation Outcomes (NIVO) score: prediction of in-hospital mortality in exacerbations of COPD requiring assisted ventilation. Eur Respir J. 2021 Aug 12;58(2):2004042. doi: 10.1183/13993003.04042-2020. Print 2021 Aug.
PubMed 33479109Steer J, Gibson J, Bourke SC. The DECAF Score: predicting hospital mortality in exacerbations of chronic obstructive pulmonary disease. Thorax. 2012 Nov;67(11):970-6. doi: 10.1136/thoraxjnl-2012-202103. Epub 2012 Aug 15.
PubMed 22895999
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Novel Bed Side Scores as Predictors of Hospital Outcome in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Among Women; Cohort Study
- ClinicalTrials.gov ID
- NCT05370664
- Acronym / sponsor ID
- Mortality outcome in COPD
- Conditions
- COPD Exacerbation
- Keywords
- NIVO, DECAF, HACOR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 11 May 2022 (actual)
- 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.
- Assess predictors of mortality in COPD exacerbation between men and women.
- Evaluate the clinical outcomes in acute exacerbation of COPD in women.
- Evaluate the validity of new scoring systems ( NIVO, DECAF, HACOR ) as a predictor for hospital outcome in acute exacerbation of COPD.
- Compare these new scoring system with the most widely used APACHE IV.
- Assessment of serum level of granulocyte colony stimulating factor ( GM-CSF) in detecting the severity of COPD exacerbation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female COPD | – | – |
| Male COPD | – | – |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in the study will be subjected to the following: A- Careful History Taking and clinical examination. B- Laboratory investigations which include : I. Complete blood count. II. Arterial blood gas. III. Liver \& kidney function tests. IV. Blood sugar level \& serum electrolytes. V. Serum granulocyte colony-stimulating factor ( GM-CSF) C- Severity of illness assessed by: I. NIVO Score ( Non-invasive outcomes score ) II. DECAF Score III. HACOR Score IV. ( Acute physiology and chronic health evaluation ) APACHE IV Score. 200 patients (100 females, 100 males) with acute exacerbation of COPD will be admitted to the RICU will be observed as regards temperature, blood pressure, respiratory rate, pulse, oxygen saturation, and arterial blood gas will be obtained on NIV. colony-stimulating factor will also be assessed on the first day of admission and after weaning from NIV.
Key inclusion criteria (1 listed)
- Patients with AECOPD leading to hypoxemia, hypercapnia and respiratory acidosis with pH < 7.35 and PaCO2 > 45 mm of Hg will be admitted to the respiratory intensive care unit (ICU) for NIV or the ward will be eligible for inclusion and not in need for mechanical ventilation
Key exclusion criteria (3 listed)
- Requirement for emergency intubation.
- Other contraindications to NIPPV including cardiac or respiratory arrest; nonrespiratory organ failure (eg, severe encephalopathy, severe gastrointestinal bleeding, hemodynamic instability with or without unstable cardiac angina); facial surgery or trauma; upper-airway obstruction; inability to protect the airway and/or high risk of aspiration; and inability to clear secretions.(6)
- Age < 35 years.
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
Mortality rate among COPD patients hospitalized due to acute exacerbation.
Time frame: 28 days from admissiom
Assessment of mortality with different scoring systems in acute exacerbation of COPD
Early prediction of NIV failure.
Time frame: 48 hours from ICU admission
Using NIVO score for Acute exacerbaion of COPD Non-invasive ventilation outcomes score is considered to be Low risk ( 0-2) Moderate risk (3-4) High risk (5-6) Very high risk ( 7-9)
Assessment of GM-CSF as a biomarker for successful therapy in acute exacerbation of COPD.
Time frame: baseline
Assessment of granulocyte colony stimulating factor by ELISA test in acute exacerbation of COPD
1 secondary outcome
Assisted ventilation days.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Background: PubMed 33146552Halpin DMG, Criner GJ, Papi A, Singh D, Anzueto A, Martinez FJ, Agusti AA, Vogelmeier CF. Global Initiative for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease. The 2020 GOLD Science Committee Report on COVID-19 and Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2021 Jan 1;203(1):24-36. doi: 10.1164/rccm.202009-3533SO.
- Background: PubMed 34350278Chakrabarti A, Mar JS, Choy DF, Cao Y, Rathore N, Yang X, Tew GW, Li O, Woodruff PG, Brightling CE, Grimbaldeston M, Christenson SA, Bafadhel M, Rosenberger CM. High serum granulocyte-colony stimulating factor characterises neutrophilic COPD exacerbations associated with dysbiosis. ERJ Open Res. 2021 Aug 2;7(3):00836-2020. doi: 10.1183/23120541.00836-2020. eCollection 2021 Jul.
- Background: PubMed 27816445Jenkins CR, Chapman KR, Donohue JF, Roche N, Tsiligianni I, Han MK. Improving the Management of COPD in Women. Chest. 2017 Mar;151(3):686-696. doi: 10.1016/j.chest.2016.10.031. Epub 2016 Nov 2.
- Background: PubMed 31565779Duan J, Wang S, Liu P, Han X, Tian Y, Gao F, Zhou J, Mou J, Qin Q, Yu J, Bai L, Zhou L, Zhang R. Early prediction of noninvasive ventilation failure in COPD patients: derivation, internal validation, and external validation of a simple risk score. Ann Intensive Care. 2019 Sep 30;9(1):108. doi: 10.1186/s13613-019-0585-9.
- Background: PubMed 33479109Hartley T, Lane ND, Steer J, Elliott MW, Sovani MP, Curtis HJ, Fuller ER, Murphy PB, Shrikrishna D, Lewis KE, Ward NR, Turnbull CD, Hart N, Bourke SC. The Noninvasive Ventilation Outcomes (NIVO) score: prediction of in-hospital mortality in exacerbations of COPD requiring assisted ventilation. Eur Respir J. 2021 Aug 12;58(2):2004042. doi: 10.1183/13993003.04042-2020. Print 2021 Aug.
- Background: PubMed 22895999Steer J, Gibson J, Bourke SC. The DECAF Score: predicting hospital mortality in exacerbations of chronic obstructive pulmonary disease. Thorax. 2012 Nov;67(11):970-6. doi: 10.1136/thoraxjnl-2012-202103. Epub 2012 Aug 15.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by Assiut University.
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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Khaled Essmat Hussien, MSSH (01003382727, khaledessmat90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate among COPD patients hospitalized due to acute exacerbation. (time frame: 28 days from admissiom). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370664, which also lists 6 linked publications.
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 15 Jun 2022.