Skip to main content
OpenTrials
Completed

NCT Number: NCT04659876

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 and Mortality COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diyarbakır Gazi Yaşargil Training and Research Hospital

Diyarbakır, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acute Physiology and Chronic Health Evaluation II Score

    Time frame: APACHE II score on the first admission of ICU

    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.

  2. Sequential Organ Failure Assessment Score

    Time frame: SOFA score on the first admission of ICU

    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.

  3. Kidney Disease: Improving Global Outcomes Scores

    Time frame: When the patients were admitted to ICU for the first time.

    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.

  4. White Blood Cell

    Time frame: At ICU admission

    White blood cell count was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  5. Neutrophil

    Time frame: When the patients were admitted to ICU for the first time

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  6. Lymphocyte

    Time frame: When the patients were admitted to ICU for the first time

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  7. Neutrophil Lymphocyte Ratio

    Time frame: the first admission to ICU

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  8. Comorbidities

    Time frame: When the patients were admitted to ICU for the first time

    The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.

  9. Diabetes

    Time frame: When the patients were admitted to ICU for the first time

    The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.

  10. Hypertension

    Time frame: When the patients were admitted to ICU for the first time

    The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.

  11. Chronic Obstructive Pulmonary Disease

    Time frame: When the patients were admitted to ICU for the first time

    The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.

  12. Chronic Kidney Disease

    Time frame: When the patients were admitted to ICU for the first time

    The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.

  13. Cardiovascular Disease

    Time frame: When the patients were admitted to ICU for the first time

    The presence of this comorbidity was determined based on medical history documented in medical records at ICU admission.

  14. Hemoglobin

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  15. Hematocrit

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  16. Platelet

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  17. Prothrombin Time

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  18. D-dimer

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  19. Blood Gas Analysis-pH

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  20. Partial Oxygen Pressure

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  21. Partial Pressure of Carbon Dioxide

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  22. Bicarbonate

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  23. Lactate

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  24. Lactate Dehydrogenase

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  25. Creatine Kinase

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  26. C-reactive Protein

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  27. Blood Urea Nitrogen

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  28. Creatinine

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  29. Alanine Aminotransferase

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  30. Aspartate Aminotransferase

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  31. Total Bilirubin

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  32. Direct Bilirubin

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  33. Indirect Bilirubin

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  34. Procalcitonin

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

  35. Ferritin

    Time frame: At ICU admission (first laboratory measurement after ICU admission)

    This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.

Secondary outcomes

  1. Length of Stay in the Intensive Care Unit

    Time frame: Three months

    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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2020
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.