Clinical trial NCT06330883: Determining the Prevalence of Frailty and Evaluating Its Relationship With Mortality.
Official title: Determining the Prevalence of Frailty in COVID-19 Patients Admitted to the Intensive Care Unit and Evaluating Its Relationship With Mortality.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Mortality
COVID-19
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Trauma patient
* Pregnant

Primary outcomes:
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
measure: The Sequential Organ Failure Assessment Score, The Acute Physiology and Chronic Health Evaluation II Score
timeFrame: First 24 hours after admission intensive care unit
measure: Thorax computed tomography (CT) imaging
timeFrame: Within 2 weeks prior to admission ICU
measure: Laboratory values
timeFrame: Routine values at admission ICU
measure: Respiratory support
timeFrame: As long as the patient stays in the intensive care unit
measure: Vasoactive drugs administered
timeFrame: Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
measure: Renal replacement therapy
timeFrame: Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
measure: Patient positions
timeFrame: Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
measure: Length of stay in the intensive care unit
timeFrame: Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University Hospital
state: Selçuklu
Study officials:
affiliation: Selcuk University Hospital, Department of Anesthesiology and Reanimation, jalecelik@hotmail.com
name: Jale Bengi Çelik
role: STUDY_DIRECTOR
References: