---
title: Factors Affecting Mortality in Critical Patients Admitted to Intensive Care Unit Due to Coronavirus Disease 2019
nct_id: NCT04659876
overall_status: COMPLETED
sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
study_type: OBSERVATIONAL
primary_condition: Covid19 and Mortality
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04659876.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04659876"
ct_last_update_post_date: 2026-01-12
last_seen_at: "2026-05-12T06:01:41.969Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Factors Affecting Mortality in Critical Patients Admitted to Intensive Care Unit Due to Coronavirus Disease 2019

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

**NCT ID:** [NCT04659876](https://clinicaltrials.gov/study/NCT04659876)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 445
- **Lead Sponsor:** Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- **Conditions:** Covid19 and Mortality
- **Start Date:** 2020-03-22
- **Completion Date:** 2020-12-08
- **CT.gov Last Update:** 2026-01-12

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Grup S (Survivors)** — Survivors in ICU follow-up
- **Grup NS (Nonsurvivors)** — Patients who died in ICU follow-up

## 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.

## Primary Outcomes

- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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.
- **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

- **Length of Stay in the Intensive Care Unit** _(time frame: Three months)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.diyarbakır gazi yaşargil training and research hospital|diyarbakır||turkey (türkiye)` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04659876*  
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