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

June 12, 2022 updated by: Khaled Essmat Hussien, Assiut University
  • 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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Female COPD
Male COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days from admissiom
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)
48 hours from ICU admission
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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assisted ventilation days.
Time Frame: Baseline
Estimating the number of days required for either non-invasive or invasive mechanical ventilation
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

May 7, 2022

First Submitted That Met QC Criteria

May 7, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 12, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mortality outcome in COPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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