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Completed

NCT Number: NCT06330883

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

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.

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Key information

Conditions

Frailty COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mortality Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University Hospital

Konya, Selçuklu, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Trauma patient
  • Pregnant

Treatment and study plan

Prognosis

Diagnostic Test

survival/mortalite

Primary outcomes

  1. Mortality

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: First 24 hours after admission intensive care unit

    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. İncreasing scores are associated with increased hospital mortality.

  2. Thorax computed tomography (CT) imaging

    Time frame: Within 2 weeks prior to admission ICU

    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.

  3. Laboratory values

    Time frame: Routine values at admission ICU

    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

  4. Respiratory support

    Time frame: As long as the patient stays in the intensive care unit

    Type (invasive/non-invasive positive pressure respiratory support or high-flow nasal oxygen therapy), duration will be recorded

  5. Vasoactive drugs administered

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

    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.

  6. Renal replacement therapy

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

    Total time the patient used renal replacement therapy as long as he stayed in the intensive care unit

  7. Patient positions

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

    Patient positions will be recorded as supine, lateral decubitus, and prone.

  8. Length of stay in the intensive care unit

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

    The number of calendar days from the date of admission to the intensive care unit until discharge

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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