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

Sepsis Clinical Trial

— RANCH-COVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05181696
• Other study ID #: OsijekUH-RC
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: Osijek University Hospital
• Contact: Nenad Neškovic, PhD
• Phone: +395996787250
• Email: nneskov[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Multiorgan Failure
• Multiple Organ Failure
• Pneumonia
• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease
• Sepsis

Intervention

Diagnostic Test:
• Chest X-ray
Retrospective analysis of chest x-rays of patients with COVID-19

Locations

Country	Name	City	State
Croatia	University hospital Osijek	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Osijek University Hospital

Country where clinical trial is conducted

Croatia, 

References & Publications (5)

Booth A, Reed AB, Ponzo S, Yassaee A, Aral M, Plans D, Labrique A, Mohan D. Population risk factors for severe disease and mortality in COVID-19: A global systematic review and meta-analysis. PLoS One. 2021 Mar 4;16(3):e0247461. doi: 10.1371/journal.pone.0247461. eCollection 2021. — View Citation

Borghesi A, Maroldi R. COVID-19 outbreak in Italy: experimental chest X-ray scoring system for quantifying and monitoring disease progression. Radiol Med. 2020 May;125(5):509-513. doi: 10.1007/s11547-020-01200-3. Epub 2020 May 1. — View Citation

Borghesi A, Zigliani A, Masciullo R, Golemi S, Maculotti P, Farina D, Maroldi R. Radiographic severity index in COVID-19 pneumonia: relationship to age and sex in 783 Italian patients. Radiol Med. 2020 May;125(5):461-464. doi: 10.1007/s11547-020-01202-1. Epub 2020 May 1. — View Citation

Mahat RK, Panda S, Rathore V, Swain S, Yadav L, Sah SP. The dynamics of inflammatory markers in coronavirus disease-2019 (COVID-19) patients: A systematic review and meta-analysis. Clin Epidemiol Glob Health. 2021 Jul-Sep;11:100727. doi: 10.1016/j.cegh.2021.100727. Epub 2021 Mar 20. Erratum In: Clin Epidemiol Glob Health. 2022 Jan-Feb;13:100991. — View Citation

Wolff D, Nee S, Hickey NS, Marschollek M. Risk factors for Covid-19 severity and fatality: a structured literature review. Infection. 2021 Feb;49(1):15-28. doi: 10.1007/s15010-020-01509-1. Epub 2020 Aug 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest x-ray severity score	The influence of the dynamics of radiographic changes quantified by Brixia score on the outcome of COVID-19 patients will be examined	21 days
Primary	Inflammatory markers	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