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

December 18, 2025 updated by: Osman Uzundere, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
445

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
APACHE II score on the first admission of ICU
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.
SOFA score on the first admission of ICU
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.
When the patients were admitted to ICU for the first time.
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.
At ICU admission
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.
When the patients were admitted to ICU for the first time
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.
When the patients were admitted to ICU for the first time
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.
the first admission to ICU
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.
When the patients were admitted to ICU for the first time
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.
When the patients were admitted to ICU for the first time
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.
When the patients were admitted to ICU for the first time
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.
When the patients were admitted to ICU for the first time
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.
When the patients were admitted to ICU for the first time
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.
When the patients were admitted to ICU for the first time
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)
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.
At ICU admission (first laboratory measurement after ICU admission)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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