Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04669509
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2020-12-14
Brief Title:
Effect of Liver Injury on Mortality in Coronavirus Disease-2019 Patients Admitted to Intensive Care Unit
Sponsor:
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Organization:
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study Overview
Official Title:
Effect of Liver Injury on Mortality in Coronavirus Disease-2019 Patients Admitted to Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 TR Ministry of Health 20112020 Patients diagnosed with COVID-19 on the specified dates followed in the ICU older than 18 years identified as criticalserious according to the World Health Organization and provisional guidelines of the Scientific Board of the TR Ministry of Health will be included in the study
ICU patients without COVID-19 COVID-19 patients under 18 years of ageCOVID-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
ICU patients without COVID-19 COVID-19 patients under 18 years of ageCOVID-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None