AzTrials
AzTrials

Covid19 and MortalityNCT04659876

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

An observational study of Covid19 and Mortality, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19 and Mortality
What is being tested?
clinical features and laboratory values
How many people
445 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Mar 2020to 8 Dec 2020
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Diyarbakır Gazi Yaşargil Training and Research Hospital

    Diyarbakır

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Being tested
clinical features and laboratory values
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clinical features and laboratory valuesDiagnostic 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.

Study groups in NCT04659876
Study groupRoleWhat they receive
Grup S (Survivors)Survivors in ICU follow-up
Receives: Diagnostic Test: clinical features and laboratory values
Grup NS (Nonsurvivors)Patients who died in ICU follow-up
Receives: Diagnostic Test: clinical features and laboratory values

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: APACHE II score on the first admission of ICU

  2. 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.

    Measured: SOFA score on the first admission of ICU

  3. 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.

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

  4. White Blood Cell

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

    Measured: At ICU admission

  5. Neutrophil

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

    Measured: When the patients were admitted to ICU for the first time

  6. Lymphocyte

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

    Measured: When the patients were admitted to ICU for the first time

  7. Neutrophil Lymphocyte Ratio

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

    Measured: the first admission to ICU

  8. Comorbidities

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

    Measured: When the patients were admitted to ICU for the first time

  9. Diabetes

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

    Measured: When the patients were admitted to ICU for the first time

  10. Hypertension

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

    Measured: When the patients were admitted to ICU for the first time

  11. Chronic Obstructive Pulmonary Disease

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

    Measured: When the patients were admitted to ICU for the first time

  12. Chronic Kidney Disease

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

    Measured: When the patients were admitted to ICU for the first time

  13. Cardiovascular Disease

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

    Measured: When the patients were admitted to ICU for the first time

  14. Hemoglobin

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  15. Hematocrit

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  16. Platelet

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  17. Prothrombin Time

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  18. D-dimer

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  19. Blood Gas Analysis-pH

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  20. Partial Oxygen Pressure

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  21. Partial Pressure of Carbon Dioxide

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  22. Bicarbonate

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  23. Lactate

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  24. Lactate Dehydrogenase

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  25. Creatine Kinase

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  26. C-reactive Protein

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  27. Blood Urea Nitrogen

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  28. Creatinine

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  29. Alanine Aminotransferase

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  30. Aspartate Aminotransferase

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  31. Total Bilirubin

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  32. Direct Bilirubin

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  33. Indirect Bilirubin

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  34. Procalcitonin

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

  35. Ferritin

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

    Measured: At ICU admission (first laboratory measurement after ICU admission)

Secondary outcomes (1)
  1. 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.

    Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start22 Mar 2020
  3. Primary completion1 Sep 2020
  4. Study completion8 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659876
Sponsor's protocol ID
September 11, 2020: 550
Status last verified
Dec 2025
First submitted
8 Dec 2020
Last updated
12 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 33101547
  • 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.

    PubMed 32920347
  • 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.

    PubMed 33046291

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Mortality, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Physiology and Chronic Health Evaluation II Score (time frame: APACHE II score on the first admission of ICU). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04659876, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in