Performance of Novel Bed Side Scores as Predictors of Hospital Outcome in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Among Women; Cohort Study

NCT05370664 | Unknown

• 1 other identifier: Mortality outcome in COPD
• Study Type: observational
• Target: 203
• Locations: 0 countries
• Sites: N/A

Brief 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.
• 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

Outcome Measures

Primary Outcomes (3)

• Mortality rate among COPD patients hospitalized due to acute exacerbation.

  Assessment of mortality with different scoring systems in acute exacerbation of COPD

  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)

  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

  baseline

Secondary Outcomes (1)

• Assisted ventilation days.

  Baseline

Study Arms (2)

Female COPD

Male COPD

Eligibility Criteria

• Age: 35 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 33146552 BACKGROUND

• Chakrabarti 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.

  PMID: 34350278 BACKGROUND

• Jenkins 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.

  PMID: 27816445 BACKGROUND

• Duan 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.

  PMID: 31565779 BACKGROUND

• Hartley 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.

  PMID: 33479109 BACKGROUND

• Steer 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.

  PMID: 22895999 BACKGROUND

Central Study Contacts

Khaled Essmat Hussien, MSSH

CONTACT

01003382727; khaledessmat90@gmail.com

Sahar Refaat Mahmoud, MD

CONTACT

01002866364; farida62014@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of chest diseases and tuberculosis

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: May 11, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: April 1, 2025
• Last Updated: June 15, 2022

Record last verified: 2022-06