Determining the Prevalence of Frailty and Evaluating Its Relationship With Mortality.

COVID-19 Clinical Trial

Official title:

Determining the Prevalence of Frailty in COVID-19 Patients Admitted to the Intensive Care Unit and Evaluating Its Relationship With Mortality.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06330883
• Other study ID #: 2021/507
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2024
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

It is planned to include non-pregnant and non-traumatic patients over the age of 18, diagnosed with COVID-19, who are treated in the Intensive Care Unit of Selcuk University Hospital. The frailty status will be evaluated by using the clinical frailty scale at the admission of the patients to the intensive care unit. Evaluation from the patient himself, if the consciousness of the patients is clear; If not, it will be done near the patient. Patients will be divided into two groups using the clinical frailty scale (CFS) as frail if the score is ≥5 and non-fragile if the score is <5. Demographic information and vaccination status (how many dose and type) will be questioned, SOFA score, APACHE II score will be recorded. Routine examinations made from the patient file; thorax computed tomography (CT) imaging, laboratory values, respiratory support information, drug treatments applied, patient positions will be recorded. Thoracic CT scans severity scores for each of the five lung lobes: 0 for no involvement (0%), 1 for minimal involvement (1%-25%), 2 for mild involvement (26-50%), 3 for moderate involvement (51%) -75) and 4 advanced involvement (76-100%). The total severity score will be the sum of the scores of the five lobes. If the score is ≤10, it will be considered as mild involvement, and if the score is >10, it will be considered as severe involvement. Laboratory values; platelet and lymphocyte count, albumin, sodium, ferritin, D-dimer, crp, procalcitonin, interleukin-6 and glomerular filtration rate values, neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, CRP/Albumin ratio, arterial blood gas will be recorded. Whether or not he received respiratory support; type (invasive/non-invasive positive pressure respiratory support or high-flow nasal oxygen therapy), duration will be recorded. The use and duration of vasoactive drugs administered, renal replacement therapy and its durations will be recorded. Patient positions will be recorded as supine, lateral decubitus, and prone. The length of stay in the intensive care unit and mortality of the patients will be recorded. Comparisons will be made between frail and non-fragile groups on all these evaluated parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Trauma patient
• Pregnant

Related Conditions & MeSH terms

• COVID-19
• Frailty
• Mortality

Intervention

Diagnostic Test:
• Prognosis
survival/mortalite

Locations

Country	Name	City	State
Turkey	Selcuk University Hospital	Konya	Selçuklu

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality rate in the first 6 months after inyensive care unit admission	6 months
Secondary	The Sequential Organ Failure Assessment Score, The Acute Physiology and Chronic Health Evaluation II Score	The Sequential Organ Failure Assessment score can range from a minimum of 0 to a maximum of 24 scores. Increasing scores are associated with increased hospital mortality. The Acute Physiology and Chronic Health Evaluation II Score can range from a minimum of 0 to a maximum of 71 scores. Increasing scores are associated with increased hospital mortality.	First 24 hours after admission intensive care unit
Secondary	Thorax computed tomography (CT) imaging	Thoracic CT scans severity scores for each of the five lung lobes: 0 for no involvement (0%), 1 for minimal involvement (1%-25%), 2 for mild involvement (26-50%), 3 for moderate involvement (51%) -75) and 4 advanced involvement (76-100%). The total severity score will be the sum of the scores of the five lobes. If the score is =10, it will be considered as mild involvement, and if the score is >10, it will be considered as severe involvement.	Within 2 weeks prior to admission ICU
Secondary	Laboratory values	Platelet and lymphocyte count, albumin, sodium, ferritin, D-dimer, crp, procalcitonin, interleukin-6 and glomerular filtration rate values, neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, CRP/Albumin ratio, arterial blood gas will be recorded	Routine values at admission ICU
Secondary	Respiratory support	Type (invasive/non-invasive positive pressure respiratory support or high-flow nasal oxygen therapy), duration will be recorded	As long as the patient stays in the intensive care unit
Secondary	Vasoactive drugs administered	Starting from the admission of patients to the intensive care unit, vasoactive drug records will be kept daily until either the patient's mortality in the intensive care unit or their discharge from the intensive care unit, up to a maximum of 6 months from admission to the intensive care unit.	Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
Secondary	Renal replacement therapy	Total time the patient used renal replacement therapy as long as he stayed in the intensive care unit	Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
Secondary	Patient positions	Patient positions will be recorded as supine, lateral decubitus, and prone.	Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
Secondary	Length of stay in the intensive care unit	The number of calendar days from the date of admission to the intensive care unit until discharge	Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.