Effect of Liver Injury on Mortality in Coronavirus Disease-2019 Patients Admitted to Intensive Care Unit

Overview

In addition to primarily affecting the lungs, coronavirus disease-2019 (COVID-19) disease can also affect many different organs, especially the heart, kidneys, liver and brain. In this group of patients, the impact of an important organ such as the liver can lead to a further deterioration of the clinical course. In this study, critical patients admitted to Gazi Yasargil Training and Research Hospital intensive care unit (ICU) due to COVID-19 between April 1 and October 1, 2020 were retrospectively analyzed. The effect of liver damage on mortality in critical COVID-19 patients was investigated. The necessary permits for the study were obtained from the Scientific Research Platform of the T.R. Ministry of Health. (20.11.2020) Patients diagnosed with COVID-19 on the specified dates, followed in the ICU, older than 18 years, identified as critical/serious according to the World Health Organization and provisional guidelines of the Scientific Board of the T.R. Ministry of Health will be included in the study. ICU patients without COVID-19, COVID-19 patients under 18 years of age,COVID-19 patients with known liver disease, and COVID-19 patients with mild to moderate symptoms will be excluded from the study. Patients' age, gender, comorbidity, Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA) scores when first admitted to the ICU, hemogram parameters (white blood cell count, neutrophil, lymphocyte, hemoglobin, platelet count), coagulation parameters (prothrombin time, activated partial thromboplastin time and D-dimer, blood biochemistry results (C-reactive protein, lactate dehydrogenase, creatine kinase , alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, direct bilirubin and indirect bilirubin), procalcitonin and ferritin levels will be recorded. In addition, the number of days spent in the ICU and whether mortality develops or not will be recorded. It will also be recorded whether mortality develops on day 7 and day 28. Patients will be divided into three groups according to their ALT, AST and total bilirubin levels at the time of admission to the ICU. Group 1 will consist of patients with normal ALT, AST and total bilirubin values. Group 2 will consist of patients whose ALT, AST or total bilirubin levels are up to 3 times upper limit of normal. Group 3 will consist of patients whose ALT, AST or total bilirubin levels are increased more than 3 times upper limit of normal.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: October 1, 2020

Interventions

  • Diagnostic Test: Liver function tests
    • Patients’ age, gender, comorbidity, Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA) scores when first admitted to the ICU, hemogram parameters (white blood cell count, neutrophil, lymphocyte, hemoglobin, platelet count), coagulation parameters (prothrombin time, activated partial thromboplastin time and D-dimer, blood biochemistry results (C-reactive protein, lactate dehydrogenase, creatine kinase , alanine aminotransferase, aspartate aminotransferase, total bilirubin, direct bilirubin and indirect bilirubin), procalcitonin and ferritin levels will be recorded. In addition, the number of days spent in the ICU and whether mortality develops or not will be recorded. It will also be recorded whether mortality develops on day 7 and day 28.

Arms, Groups and Cohorts

  • Group 1
    • Patients with normal ALT, AST and total bilirubin values
  • Group 2
    • Patients whose ALT, AST or total bilirubin levels are up to 3 times upper limit of normal
  • Group 3
    • Patients whose ALT, AST or total bilirubin levels are increased more than 3 times upper limit of normal

Clinical Trial Outcome Measures

Primary Measures

  • 7 and 28 day mortality
    • Time Frame: Patients hospitalized in the ICU within 6 months
    • Effect of Liver Injury on Mortality

Participating in This Clinical Trial

Inclusion Criteria

  • Patients diagnosed with COVID-19 on the specified dates, followed in the ICU, older than 18 years, identified as critical/serious according to the World Health Organization and provisional guidelines of the Scientific Board of the T.R. Ministry of Health will be included in the study. Exclusion Criteria:

  • ICU patients without COVID-19, COVID-19 patients under 18 years of age,COVID-19 patients with known liver disease, and COVID-19 patients with mild to moderate symptoms will be excluded from the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cem Kıvılcım Kaçar, Anesthesiology and reanimation specialist – Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

References

Cai Q, Huang D, Yu H, Zhu Z, Xia Z, Su Y, Li Z, Zhou G, Gou J, Qu J, Sun Y, Liu Y, He Q, Chen J, Liu L, Xu L. COVID-19: Abnormal liver function tests. J Hepatol. 2020 Sep;73(3):566-574. doi: 10.1016/j.jhep.2020.04.006. Epub 2020 Apr 13.

Huang H, Chen S, Li H, Zhou XL, Dai Y, Wu J, Zhang J, Shao L, Yan R, Wang M, Wang J, Tu Y, Ge M. The association between markers of liver injury and clinical outcomes in patients with COVID-19 in Wuhan. Aliment Pharmacol Ther. 2020 Sep;52(6):1051-1059. doi: 10.1111/apt.15962. Epub 2020 Jul 22.

Jiang S, Wang R, Li L, Hong D, Ru R, Rao Y, Miao J, Chen N, Wu X, Ye Z, Hu Y, Xie M, Zuo M, Lu X, Qiu Y, Liang T. Liver Injury in Critically Ill and Non-critically Ill COVID-19 Patients: A Multicenter, Retrospective, Observational Study. Front Med (Lausanne). 2020 Jun 23;7:347. doi: 10.3389/fmed.2020.00347. eCollection 2020.

Fan Z, Chen L, Li J, Cheng X, Yang J, Tian C, Zhang Y, Huang S, Liu Z, Cheng J. Clinical Features of COVID-19-Related Liver Functional Abnormality. Clin Gastroenterol Hepatol. 2020 Jun;18(7):1561-1566. doi: 10.1016/j.cgh.2020.04.002. Epub 2020 Apr 10.

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