Clinical trial NCT04430023: Epidemiological and Demographic Data From 150 Patients Diagnosed With Coronavirus Disease 2019 Pneumonia
Official title: Epidemiological and Demographic Data From 150 Patients Diagnosed With Coronavirus Disease 2019 Pneumonia in Intensive Care Unit- a Retrospective, Observational Study in Istanbul, Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corona Virus Infection
Pneumonia
Acute Respiratory Failure
Keywords: coronavirus disease 2019
pneumonia
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was planned retrospectively, cross-sectionally and observationally with 193 patients hospitalized between 16 March 2020 and 15 May 2020 in five different coronavirus disease 2019 intensive care units in two campuses of our hospital.

Brief summary: In this study, the investigator examined epidemiological and demographic characteristics, risk factors and 28-day mortality of patients admitted to the intensive care unit with the diagnosis of coronavirus disease 2019 pneumonia.

Detailed description: The patients with intensive care requirements were admitted from emergency department and coronavirus disease 2019 wards to our units. The criteria for intensive care requirement was identified as oxygen saturation\<90%, partial oxygen pressure\<70 mmHg, respiratory rate\> 30/min or PaO2/FiO2(partial oxygen pressure/fraction of inspired oxygen) \<300 despite conventional oxygen treatment of 5lt/min. Primary objective was the effect of defined data on 28-day mortality, and secondary objective was the impact of lymphocyte count, lactate dehydrogenase, ferritin, D-dimer and procalcitonin levels, and SOFA(Sequential Organ Failure Assessment) score on prognosis, which are among the risk factors determined by previous studies. All data were evaluated and recorded using the standardized International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) case report forms, complemented by electronic records of the hospital, nurse observation records, and missing information was completed by telephone interviews with patients' relatives.

Eligibility criteria: Inclusion Criteria:

* The study was planned retrospectively, cross-sectionally and observationally with 193 patients hospitalized between 16 March 2020 and 15 May 2020 in five different coronavirus disease 2019 intensive care units in two campuses of our hospital.

Exclusion Criteria:

* Health workers, patients hospitalized less than 24 hours, patients with negative polymerase chain reaction tests, and patients who returned to intensive care unit after discharge were excluded from the study.

Primary outcomes:
measure: mortality
timeFrame: up to 28 days
measure: demographic characteristics
timeFrame: up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Etfal Research and Training Hospital
state: Marmara
Study officials:
affiliation: chief of anesthesia department
name: ayse cinar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.
citation: Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.
citation: Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.