NCT06330883

Brief Summary

Covid-19 patients admitted to the intensive care unit of Selcuk University Hospital were included in the study. Clinical frailty score was given during admission to the intensive care unit. Demographic data, laboratory data, radiological imaging and vital signs of the patients were recorded. Treatment and patient positions were recorded during the intensive care follow-up of the patients. Mortality status of the patients 6 months after admission to the ICU was recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 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

January 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

May 23, 2023

Last Update Submit

March 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality rate in the first 6 months after inyensive care unit admission

    6 months

Secondary Outcomes (8)

  • The Sequential Organ Failure Assessment Score, The Acute Physiology and Chronic Health Evaluation II Score

    First 24 hours after admission intensive care unit

  • Thorax computed tomography (CT) imaging

    Within 2 weeks prior to admission ICU

  • Laboratory values

    Routine values at admission ICU

  • Respiratory support

    As long as the patient stays in the intensive care unit

  • Vasoactive drugs administered

    Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.

  • +3 more secondary outcomes

Study Arms (2)

Frail

Patients will be evaluated frail if the clinical frailty score is ≥5

Diagnostic Test: Prognosis

non-fragile

Patients will be evaluated non-fragile if the clinical frailty score is \<5.

Diagnostic Test: Prognosis

Interventions

PrognosisDIAGNOSTIC_TEST

survival/mortalite

Frailnon-fragile

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

It is planned to include non-pregnant and non-traumatic patients over the age of 18 who are treated with the diagnosis of COVID-19 in the Intensive Care Unit of Selcuk University hospital.

You may qualify if:

  • Patients who over the age of 18
  • Patients who diagnosed with Covid-19

You may not qualify if:

  • Trauma patient
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University Hospital

Konya, Selçuklu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FrailtyCOVID-19

Interventions

Prognosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

  • Jale Bengi Çelik

    Selcuk University Hospital, Department of Anesthesiology and Reanimation, jalecelik@hotmail.com

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 23, 2023

First Posted

March 26, 2024

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations