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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04430023
Recruitment Status : Completed
First Posted : June 12, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
AYŞE SÜRHAN ÇINAR, Sisli Hamidiye Etfal Training and Research 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.

Condition or disease Intervention/treatment
Corona Virus Infection Pneumonia Acute Respiratory Failure Other: epidemiological and demographic characteristics

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.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Other
Time Perspective: Retrospective
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
Actual Study Start Date : May 15, 2020
Actual Primary Completion Date : June 3, 2020
Actual Study Completion Date : June 5, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: epidemiological and demographic characteristics
    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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430023


Locations
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Turkey
Sisli Etfal Research and Training Hospital
Istanbul, Marmara, Turkey, 34371
Sponsors and Collaborators
Sisli Hamidiye Etfal Training and Research Hospital
Investigators
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Principal Investigator: ayse cinar chief of anesthesia department
  Study Documents (Full-Text)

Documents provided by AYŞE SÜRHAN ÇINAR, Sisli Hamidiye Etfal Training and Research Hospital:
Study Protocol  [PDF] June 6, 2020
Statistical Analysis Plan  [PDF] June 6, 2020

Publications of Results:
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Responsible Party: AYŞE SÜRHAN ÇINAR, head of anesthesiology, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04430023    
Other Study ID Numbers: DM3334
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AYŞE SÜRHAN ÇINAR, Sisli Hamidiye Etfal Training and Research Hospital:
coronavirus disease 2019
pneumonia
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiration Disorders