FrailtyNCT06330883
Determining the Prevalence of Frailty and Evaluating Its Relationship With Mortality.
An observational study of Frailty and Mortality, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Prognosis
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients who over the age of 18
- Patients who diagnosed with Covid-19
Who cannot join
- Trauma patient
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Prevalence of Frailty in COVID-19 Patients Admitted to the Intensive Care Unit 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.
Read the 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.
- Being tested
- Prognosis
- Medical subject headings
- Frailty, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrognosisDiagnostic test
survival/mortalite
| Study group | Role | What they receive |
|---|---|---|
| Frail | Patients will be evaluated frail if the clinical frailty score is ≥5 Receives: Diagnostic Test: Prognosis | |
| non-fragile | Patients will be evaluated non-fragile if the clinical frailty score is <5. Receives: Diagnostic Test: Prognosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality rate in the first 6 months after inyensive care unit admission
Measured: 6 months
Secondary outcomes (8)
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. İncreasing scores are associated with increased hospital mortality.
Measured: First 24 hours after admission intensive care unit
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.
Measured: Within 2 weeks prior to admission ICU
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
Measured: Routine values at admission ICU
Respiratory support
Type (invasive/non-invasive positive pressure respiratory support or high-flow nasal oxygen therapy), duration will be recorded
Measured: As long as the patient stays in the intensive care unit
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.
Measured: Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
Renal replacement therapy
Total time the patient used renal replacement therapy as long as he stayed in the intensive care unit
Measured: Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
Patient positions
Patient positions will be recorded as supine, lateral decubitus, and prone.
Measured: Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
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
Measured: Data will be collected from the admission to the intensive care unit up to 6 months or until mortality within this period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Degirmencioglu, Selcuk University
- Investigators
- Jale Bengi Çelik, Study director, Selcuk University Hospital, Department of Anesthesiology and Reanimation, jalecelik@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330883
- Sponsor's protocol ID
- 2021/507
- Status last verified
- Mar 2024
- First submitted
- 23 May 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Prevalence of Frailty in COVID-19 Patients Admitted to the Intensive Care Unit and Evaluating Its Relationship With Mortality.
- ClinicalTrials.gov ID
- NCT06330883
- Acronym / sponsor ID
- 2021/507
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail | – | Diagnostic Test: PrognosisPatients will be evaluated frail if the clinical frailty score is ≥5 |
| non-fragile | – | Diagnostic Test: PrognosisPatients will be evaluated non-fragile if the clinical frailty score is <5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who over the age of 18
- Patients who diagnosed with Covid-19
Key exclusion criteria (2 listed)
- Trauma patient
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prognosissurvival/mortalite | Diagnostic test | Frail, non-fragile |
Primary outcome
Mortality
Time frame: 6 months
Mortality rate in the first 6 months after inyensive care unit admission
8 secondary outcomes
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
Thorax computed tomography (CT) imaging
Time frame: Within 2 weeks prior to admission ICU
Laboratory values
Time frame: Routine values at admission ICU
Respiratory support
Time frame: As long as the patient stays in the intensive care unit
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jale Bengi Çelik study director
Selcuk University Hospital, Department of Anesthesiology and Reanimation, jalecelik@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Mortality, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.