Retrospective Analysis of Chest X-ray Severity Scoring System of COVID-19 Pneumonia (RANCH-COVID)

July 14, 2023 updated by: Osijek University Hospital

Radiographic Severity Scoring System and Clinical and Laboratory Evolution of COVID-19 Pneumonia

The research will be retrospective, and will include all patients who were admitted during 2020 and 2021 in the COVID-19 ICU of University Hospital Center Osijek due to pneumonia caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The association of chest x-ray infiltrate evolution with changes in laboratory inflammatory parameters and respiratory function parameters will be examined.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The research will be retrospective, and will include a review of medical history of all patients admitted in the COVID-19 ICU of the University hospital Osijek during 2020 and 2021. Associated comorbidity, hospital admission date, intubation date, mechanical ventilation, extubation, discharge, and patient final outcome will be recorded for each patient. By analyzing X-rays of the lungs by radiology specialists, inflammatory infiltrates in the lungs will be quantified via the Brixia system, during hospital admission, admission to the Respiratory Center, and during treatment at the Respiratory Center. All patients will have their Sequential Organ Failure Assessment (SOFA) and/or Acute Physiology and Chronic Health Evaluation (APACHE II) values calculated upon admission. Inflammatory parameters (c-reactive protein (CRP), procalcitonin (PCT), interleukine-6 (IL-6), ferritin), red blood cell count, leukocytes, blood urea nitrogen (BUN), arterial blood gases and ventilation parameters on admission to the hospital, admission to the ICU, and on several occasions during treatment in the ICU will be analysed. Also, empirical use of antibiotics, the occurrence of bacterial superinfections, sepsis and organic failure will be noted.

Study Type

Observational

Enrollment (Estimated)

1000

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

  • Name: Ivana Haršanji Drenjančević, PhD
  • Phone Number: +385915108941
  • Email: ihdrenjan@gmail.com

Study Locations

  • Croatia
      • Osijek, Croatia, 31000
        • Recruiting
        • University Hospital Osijek
        • Contact:

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients treated in ICU COVID-19 with a diagnosis of pneumonia will be analyzed retrospectively.

Description

Inclusion Criteria:

  • Pneumonia caused by SARS-CoV-2 virus
  • Admission to the ICU COVID-19 unit

Exclusion Criteria:

- Patients with lung tumors or history of lung resection

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
Intervention / Treatment
COVID-19 pneumonia patients
Patients treated at the University Hospital Osijek Respiratory Center with pneumonia caused by SARS-CoV-2
Diagnostic test: Chest X-ray
Retrospective analysis of chest x-rays of patients with COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest x-ray severity score
Time Frame: 21 days
The influence of the dynamics of radiographic changes quantified by Brixia score on the outcome of COVID-19 patients will be examined
21 days
Inflammatory markers
Time Frame: 21 days
The influence of serum levels of inflammatory parameters, and clinical and laboratory indicators of organic failure on chest x-ray severity score will be examined
21 days

Collaborators and Investigators

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

Sponsor

Osijek University Hospital

Investigators

  • Principal Investigator: Nenad Neskovic, PhD, University Hospital Osijek

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 (Actual)

January 1, 2020

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OsijekUH-RC

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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