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

NCT04659876 | Completed Results

• 1 other identifier: September 11, 2020: 550
• Study Type: observational
• Target: 445
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19 and Mortality

Outcome Measures

Primary Outcomes (35)

• 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 Outcomes (1)

• Length of Stay in the Intensive Care Unit

  Three months

Study Arms (2)

Grup S (Survivors)

Survivors in ICU follow-up

Diagnostic Test: clinical features and laboratory values

Grup NS (Nonsurvivors)

Patients who died in ICU follow-up

Diagnostic Test: clinical features and laboratory values

Interventions

clinical features and laboratory values DIAGNOSTIC_TEST

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); Grup S (Survivors)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Diyarbakır Gazi Yaşargil Training and Research Hospital

Diyarbakır, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33101547 BACKGROUND

• 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.

  PMID: 32920347 BACKGROUND

• 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.

  PMID: 33046291 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Osman Uzundere
• Organization: SBU Gazi Yaşargil Training and Research Hospital

osmanuzundere@gmail.com

+905330206362

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and reanimation specialist

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 9, 2020
• Study Start: March 22, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 8, 2020
• Last Updated: January 12, 2026
• Results First Posted: January 12, 2026

Record last verified: 2025-12

Locations

TU (1)