NCT06043115

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
619

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

September 9, 2023

Last Update Submit

September 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • factors affecting mortality in COVID-19

    clinical and laboratory characteristics of COVID-19 patients in mortality of ICU.

    11 March 2020 -31 March 2022

Secondary Outcomes (1)

  • difference between the pandemic waves

    11 March 2020-31 March 2022

Study Arms (2)

covid-19 survival cohort

consists of surviving patients

Other: covid-19 survival cohort

covid-19 mortality cohort

consists of deceased patients

Other: covid-19 mortality cohort

Interventions

consists of surviving patients

covid-19 survival cohort

consists of deceased patients

covid-19 mortality cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Antalya, Turkey (Türkiye)

Location

Study Officials

  • Burcu Ozer, MD

    Akdeniz University School of Medicine, Department of Anesthesiology and Reanimation, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,Professor Doctor

Study Record Dates

First Submitted

September 9, 2023

First Posted

September 21, 2023

Study Start

May 11, 2022

Primary Completion

November 30, 2022

Study Completion

December 15, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations