Factors Affecting Mortality in Covid-19 Disease

September 15, 2023 updated by: Melike Cengiz
The coronavirus disease-19 (COVID-19), defined by the reporting of pneumonia cases of unknown etiology at the end of 2019 in Wuhan, China, has spread worldwide, causing millions of deaths. Despite the fact that more than two years have passed since the struggle against the disease it continues to be an important public health problem.The increasing number of critically ill patients with this pandemic caused a great demand for intensive care units (ICU), and ICU capacity and staff had to be rapidly expanded in many countries. Similarly, in various periods of the pandemic in Turkey, the capacity of many ICUs had to be increased. The rates of admission to the ICU and death rates differed greatly from center to center due to various factors such as ICU bed capacity and the duration of access to the ICU, patient characteristics, and differences in the treatments applied. Determining the factors that may be associated with mortality is important in terms of improving the ICU follow-up of patients with COVID-19 and guiding their treatment.There is limited information about the characteristics and mortality of Turkish patients with COVID-19 in the ICU. The aim of this study is to determine the demographic, clinical and laboratory characteristics and the factors affecting ICU mortality in COVID-19 patients followed in Akdeniz University Medical Faculty Hospital since the beginning of the pandemic.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It was designed as a retrospective cohort study in which patients with a diagnosis of COVID-19 hospitalized in the ICU between 11 March 2020 and 31 March 2022 were included.

Patients aged ≥18 years with a confrmed diagnosis of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection by a positive real-time reverse-transcription polymerase chain reaction test (RT-PCR) on a nasopharyngeal swab or or endotracheal aspirate were included in the present study. The study data collected from the patient record at ICU admission included demographic characteristics (age, sex, body mass index), smoking history, comorbidities, vaccination status, Acute Physiology and Chronic Health Evaluation II (APACHE II) score, Sequential Organ Failure Assessment (SOFA) score, laboratory findings, blood gas analysis (PaO2/FiO2 ratio), oxygen device method, lenght of stay ICU and hospital duration and COVID-19 related complications. Laboratory findings included a complete blood count, coagulation testing, D-dimer, blood chemical analysis, C-reactive protein (CRP), assessment of liver and renal function, procalcitonin, and microbial cultures results. Additional adjunctive support, including extracorporeal membrane oxygenation (ECMO), prone positioning, renal replacement therapy (RRT) were documented daily. Information on patient-specific therapies, such as administration of hydroxychloroquine, antivirals, convalescent plasma and plasmapheresis was also collected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
619

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged ≥18 years with a confrmed diagnosis of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection by a positive real-time reverse-transcription polymerase chain reaction test (RT-PCR) on a nasopharyngeal swab or endotracheal aspirate were included in the present study.

Description

Inclusion Criteria:

  • Patients aged ≥18 years with a confrmed diagnosis of the severe acute respiratory syndrome coronavirus-2 infection by a positive real-time reverse-transcription polymerase chain reaction test

Exclusion Criteria:

  • Patients whose SARS-CoV-2 RT-PCR test was negative
  • Chest computed tomography findings or symptoms were not compatible with COVID-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
covid-19 survival cohort
consists of surviving patients
Other: covid-19 survival cohort
consists of surviving patients
covid-19 mortality cohort
consists of deceased patients
Other: covid-19 mortality cohort
consists of deceased patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
factors affecting mortality in COVID-19
Time Frame: 11 March 2020 -31 March 2022
clinical and laboratory characteristics of COVID-19 patients in mortality of ICU.
11 March 2020 -31 March 2022

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
difference between the pandemic waves
Time Frame: 11 March 2020-31 March 2022
mortality rate of ICU, clinical and laboratory characteristics of COVID-19 patients according to pandemic waves
11 March 2020-31 March 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Melike Cengiz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Burcu Ozer, MD, Akdeniz University School of Medicine, Department of Anesthesiology and Reanimation, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Akdeniz University Faculty

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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