Factors Affecting Mortality in Critical Patients Admitted to Intensive Care Unit Due to Coronavirus Disease 2019

Clinical Characteristics and Laboratory Values Affecting Mortality in Critical Coronavirus Disease 2019 Patients Followed in the Intensive Care Unit

Gazi Yasargil Training and Research Hospital, located in Diyarbakır province in southeastern Turkey, was designed as a pandemic hospital from the beginning of the coronavirus disease-2019 (COVID-19) outbreak. The first cases in this region were seen on March 22, 2020. In this study, it is aimed to retrospectively examine critical patients admitted to the intensive care unit (ICU) due to COVID-19 from the first onset of cases until September 01, 2020 and to examine the factors affecting mortality. The necessary permits for the study were obtained from the Scientific Research Platform of the T.R. Ministry of Health and the Ethics Committee of the Gazi Yasargil educational and Research Hospital in Diyarbakır. (No: 550, 11.09.2020) 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 mild to moderate symptoms, no respiratory distress, no signs of common pneumonia on lung radiography or tomography will be excluded from the study.

Patients' age, gender, comorbidity, Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA) and Kidney Disease: Improving Global Outcomes (KDIGO) scores when first admitted to the ICU, hemogram parameters (white blood cell count, neutrophil, lymphocyte, neutrophil / lymphocyte ratio, hemoglobin, hematocrit, platelet count), blood gas information (pH, Partial oxygen pressure-PO2, Partial pressure of carbon dioxide-PCO2, bicarbonate-HCO3, lactate), coagulation parameters (prothrombin time and D-dimer, blood biochemistry results (C-reactive protein, lactate dehydrogenase, creatine kinase , urea, creatinine, 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.

Patients will be divided into two groups according to their clinical results as those without mortality during ICU follow-up (Group S) and those with mortality (Group NS). The clinical characteristics of both groups, APACHE II, SOFA, KDIGO scores and laboratory results at the first admission to the ICU will be compared. With the diagnosis of COVID-19, factors affecting mortality in critical patients in the ICU will be tried to be determined.

Study Overview

• Status: Completed
• Conditions: Covid19 and Mortality
• Intervention / Treatment: Diagnostic test: clinical features and laboratory values

• Study Type: Observational
• Enrollment (Actual): 445

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Diyarbakır, Turkey (Türkiye)
    • Diyarbakır Gazi Yaşargil Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Critical patients over the age of 18 who were admitted to the ICU

Description

Inclusion Criteria:

• During the period between 22.03.2020 and 01.09.2020, critical patients over the age of 18 who were admitted to the ICU of Diyarbakır Gazi Yasargil Educational and Research Hospital due to COVID-19 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 mild to moderate symptoms, no respiratory distress, no signs of common pneumonia on lung radiography or tomography

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Grup S (Survivors); Survivors in ICU follow-up	Diagnostic test: clinical features and laboratory values; Patients' age, gender, comorbidity, APACHE II, SOFA and KDIGO scores when first admitted to the ICU, performing hemogram (WBC, neutrophil, lymphocyte, neutrophil / lymphocyte ratio, hemoglobin, hematocrit, platelet count), blood gas information (pH, PO2, PCO2, HCO3, lactate), coagulation parameters PTZ and D-dimer, blood biochemistry results (CRP, LDH, CK, urea, creatinine, ALT, 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.
Grup NS (Nonsurvivors); Patients who died in ICU follow-up	Diagnostic test: clinical features and laboratory values; Patients' age, gender, comorbidity, APACHE II, SOFA and KDIGO scores when first admitted to the ICU, performing hemogram (WBC, neutrophil, lymphocyte, neutrophil / lymphocyte ratio, hemoglobin, hematocrit, platelet count), blood gas information (pH, PO2, PCO2, HCO3, lactate), coagulation parameters PTZ and D-dimer, blood biochemistry results (CRP, LDH, CK, urea, creatinine, ALT, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Physiology and Chronic Health Evaluation II Score	The score can help in the assessment of patients to determine the level & degree of diagnostic & therapeutic intervention. Interpretation of APACHE II: minimum 0 and maximum 71; increasing score is associated with an increasing risk of hospital death.	APACHE II score on the first admission of ICU
Sequential Organ Failure Assessment Score	The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category. The SOFA score is made of 6 variables, each representing an organ system. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Score ranges from 0 (best) to 24 (worst) points.	SOFA score on the first admission of ICU
Kidney Disease: Improving Global Outcomes Scores	It is a system used to determine the severity of kidney failure. It is a classification consisting of four stages: 0-1-2-3. It indicates that the level of failure worsens as the stage increases.	When the patients were admitted to ICU for the first time.
White Blood Cell	White blood cell count was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission
Neutrophil	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	When the patients were admitted to ICU for the first time
Lymphocyte	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	When the patients were admitted to ICU for the first time
Neutrophil Lymphocyte Ratio	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	the first admission to ICU
Comorbidities	The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.	When the patients were admitted to ICU for the first time
Diabetes	The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.	When the patients were admitted to ICU for the first time
Hypertension	The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.	When the patients were admitted to ICU for the first time
Chronic Obstructive Pulmonary Disease	The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.	When the patients were admitted to ICU for the first time
Chronic Kidney Disease	The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.	When the patients were admitted to ICU for the first time
Cardiovascular Disease	The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.	When the patients were admitted to ICU for the first time
Hemoglobin	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Hematocrit	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Platelet	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Prothrombin Time	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
D-dimer	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Blood Gas Analysis-pH	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Partial Oxygen Pressure	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Partial Pressure of Carbon Dioxide	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Bicarbonate	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Lactate	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Lactate Dehydrogenase	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Creatine Kinase	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
C-reactive Protein	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Blood Urea Nitrogen	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Creatinine	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Alanine Aminotransferase	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Aspartate Aminotransferase	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Total Bilirubin	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Direct Bilirubin	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Indirect Bilirubin	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Procalcitonin	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)
Ferritin	This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.	At ICU admission (first laboratory measurement after ICU admission)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay in the Intensive Care Unit	ICU length of stay was measured as the total number of days from ICU admission to ICU discharge or death, based on information recorded in medical records.	Three months

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Publications and helpful links

General Publications

• Mehraeen E, Karimi A, Barzegary A, Vahedi F, Afsahi AM, Dadras O, Moradmand-Badie B, Seyed Alinaghi SA, Jahanfar S. Predictors of mortality in patients with COVID-19-a systematic review. Eur J Integr Med. 2020 Dec;40:101226. doi: 10.1016/j.eujim.2020.101226. Epub 2020 Oct 17.
• Luo M, Cao S, Wei L, Zhao X, Gao F, Li S, Meng L, Wang Y. Intubation, mortality, and risk factors in critically ill Covid-19 patients: A pilot study. J Clin Anesth. 2020 Dec;67:110039. doi: 10.1016/j.jclinane.2020.110039. Epub 2020 Sep 7. No abstract available.
• Linli Z, Chen Y, Tian G, Guo S, Fei Y. Identifying and quantifying robust risk factors for mortality in critically ill patients with COVID-19 using quantile regression. Am J Emerg Med. 2021 Jul;45:345-351. doi: 10.1016/j.ajem.2020.08.090. Epub 2020 Sep 3.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): December 8, 2020

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: September 11, 2020: 550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No