Clinical Characteristics and Laboratory Values Affecting Mortality in Critical Coronavirus Disease 2019 Patients Followed in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 445
- 试验地点
- 1
- 主要终点
- Acute Physiology and Chronic Health Evaluation II Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Acute Physiology and Chronic Health Evaluation II Score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: At ICU admission
White blood cell count was measured using routinely collected laboratory data obtained from medical records at ICU admission.
Neutrophil
时间窗: 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
时间窗: 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
时间窗: the first admission to ICU
This parameter was measured using routinely collected laboratory data obtained from medical records at ICU admission.
Comorbidities
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Length of Stay in the Intensive Care Unit(Three months)
研究者
Osman Uzundere
Anesthesiology and reanimation specialist
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital