Clinical trial NCT04659876: Factors Affecting Mortality in Critical Patients Admitted to Intensive Care Unit Due to COVID 19
Official title: Clinical Characteristics and Laboratory Values Affecting Mortality in Critical COVID 19 Patients Followed in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19 and Mortality
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critical patients over the age of 18 who were admitted to the ICU

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 our region were seen on March 22, 2020. In this study, we aim to retrospectively examine the critical patients we admitted to the intensive care unit (ICU) due to COVID-19 from the first onset of cases until September 01, 2020 to investigate 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, blood groups, 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, carbon dioxide partial pressure-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 criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: Patients hospitalized in the ICU within 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Diyarbakır Gazi Yaşargil Training and Research Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.