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Completed

NCT Number: NCT04430023

Epidemiological and Demographic Data From 150 Patients Diagnosed With Coronavirus Disease 2019 Pneumonia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sisli Etfal Research and Training Hospital

Istanbul, Marmara, 34371, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

epidemiological and demographic characteristics

Other

Patients' age, gender, BMI, medical history, symptoms at admission (e.g., cough, fever, myalgia, gastrointestinal symptoms, headache), concomitant diseases (e.g., diabetes mellitus, hypertension, chronic lung disease, cerebrovascular disease, kidney disease, heart disease, cancer, smoking

Primary outcomes

  1. mortality

    Time frame: up to 28 days

    mortality rate

  2. demographic characteristics

    Time frame: up to 28 days

    Patients' age, gender, BMI, medical history

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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