HospitalismNCT05054283
Baseline Blood Indices and Prolonged Length of Hospital Stay
An observational study of Hospitalism and COVID-19 Pneumonia, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
During a pandemic, length of hospital stay (LOS) is critical to managing high patient volumes and preserves access to care related to non-COVID-19 for maintaining the healthcare system. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hospitalism, COVID-19 Pneumonia, Diabetes Mellitus, Type 2
- What is being tested?
- Inflamatory biomarkers
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Dec 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The date of hospital admission and discharge of patients and baseline clinical characteristics including age, sex, comorbidities (hypertension, cardiovascular disease, chronic obstructive pulmonary disease and others), diabetes medications (oral anti-diabetic drugs or insulin), and laboratuary parameters of within 24 hours of admission (levels of white blood cell (WBC), lymphocyte neutrophil, hemoglobin (Hb), platelet, fasting glucose, glycated hemoglobin, aspartate aminotransferase (AST) , c-reactive protein (CRP), ferritin, and procalcitonin) were recorded from medical records and collected by two trained fellow geriatricians.
Who may be able to join
- We included all hospitalized Covid-19 patients with diabetes mellitus according to the any established diagnosis prior to admission or American Diabetes Association guidelines for diagnostic criteria
Who cannot join
- The patients with severe Covid-19 infection, secondary diabetes or type 1 diabetes mellitus were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gulhane training and research hospital
Ankara, 06670
Bilal Katipoglu, MD, +905543330380, drbilal07@gmail.com
Mehmet I Naharcı, Prof
About this study
Official title: Baseline Blood Indices as a Marker for Prolonged Length of Hospital Stay in Diabetic Older Patients With Mild or Moderate Covid-19 Infection
During a pandemic, length of hospital stay (LOS) is critical to managing high patient volumes and preserves access to care related to non-COVID-19 for maintaining the healthcare system. Moreover, identification of prolonged hospital stay may allow physicians to reevaluate critical patients, focused delivery of specific interventions, and improve the efficiency of hospital care.
Furthermore, in previous recent studies, attention has been paid to patients with diabetes and COVID-19 infection may require a prolonged LOS. However, there is little evidence on prognostic factors associated with an extension of hospitalization in mild or moderate illness due to COVID-19 infection. Therefore, it is crucial to determine the most vulnerable patients with diabetes mellitus even if they have a non-severe COVID-19 infection during the pandemic.
We hypothesize that the clinically relevant inflammatory parameters may have an impact on LOS in older adults with diabetes and non-severe COVID-19 infection. Therefore, we aim to investigate whether baseline inflammatory parameters on admission hospitals as possible predictors of prolonged LOS in older adults with diabetes and non-severe COVID-19 infection during the pandemic.
- Conditions
- Hospitalism, COVID-19 Pneumonia, Diabetes Mellitus, Type 2
- Being tested
- Inflamatory biomarkers
- Keywords
- Length of hospital stay, Covid-19 Pneumonia, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflamatory biomarkersDiagnostic test
laboratuary parameters of within 24 hours of admission (levels of white blood cell (WBC), lymphocyte neutrophil, hemoglobin (Hb), platelet, fasting glucose, glycated hemoglobin, aspartate aminotransferase (AST) , c-reactive protein (CRP), ferritin, and procalcitonin) were recorded from medical records and collected by two trained fellow geriatricians.
| Study group | Role | What they receive |
|---|---|---|
| Length of hospital Stay (normal) | The primary outcome was hospital length of stay (LOS), which was calculated according to the number of days of hospitalization. Patients were divided into two groups according to median value of LOS: ≤ 7 days as normal and > 7 days as prolonged LOS. Receives: Diagnostic Test: Inflamatory biomarkers | |
| Length of hospital Stay (prolonged) | The primary outcome was hospital length of stay (LOS), which was calculated according to the number of days of hospitalization. Patients were divided into two groups according to median value of LOS: ≤ 7 days as normal and > 7 days as prolonged LOS. Receives: Diagnostic Test: Inflamatory biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Length of hospital
The primary outcome was hospital length of stay (LOS), which was calculated according to the number of days of hospitalization.
Measured: at least 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalismStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bilal Katipoglu, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054283
- Sponsor's protocol ID
- 2020-374
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Blood Indices as a Marker for Prolonged Length of Hospital Stay in Diabetic Older Patients With Mild or Moderate Covid-19 Infection
- ClinicalTrials.gov ID
- NCT05054283
- Acronym / sponsor ID
- 2020-374
- Conditions
- Hospitalism, COVID-19 Pneumonia, Diabetes Mellitus, Type 2
- Keywords
- Length of hospital stay, Covid-19 Pneumonia, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 23 Sep 2021 (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.
During a pandemic, length of hospital stay (LOS) is critical to managing high patient volumes and preserves access to care related to non-COVID-19 for maintaining the healthcare system. Moreover, identification of prolonged hospital stay may allow physicians to reevaluate critical patients, focused delivery of specific interventions, and improve the efficiency of hospital care.
Furthermore, in previous recent studies, attention has been paid to patients with diabetes and COVID-19 infection may require a prolonged LOS. However, there is little evidence on prognostic factors associated with an extension of hospitalization in mild or moderate illness due to COVID-19 infection. Therefore, it is crucial to determine the most vulnerable patients with diabetes mellitus even if they have a non-severe COVID-19 infection during the pandemic.
We hypothesize that the clinically relevant inflammatory parameters may have an impact on LOS in older adults with diabetes and non-severe COVID-19 infection. Therefore, we aim to investigate whether baseline inflammatory parameters on admission hospitals as possible predictors of prolonged LOS in older adults with diabetes and non-severe COVID-19 infection during the pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Length of hospital Stay (normal) | – | Diagnostic Test: Inflamatory biomarkersThe primary outcome was hospital length of stay (LOS), which was calculated according to the number of days of hospitalization. Patients were divided into two groups according to median value of LOS: ≤ 7 days as normal and > 7 days as prolonged LOS. |
| Length of hospital Stay (prolonged) | – | Diagnostic Test: Inflamatory biomarkersThe primary outcome was hospital length of stay (LOS), which was calculated according to the number of days of hospitalization. Patients were divided into two groups according to median value of LOS: ≤ 7 days as normal and > 7 days as prolonged LOS. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The date of hospital admission and discharge of patients and baseline clinical characteristics including age, sex, comorbidities (hypertension, cardiovascular disease, chronic obstructive pulmonary disease and others), diabetes medications (oral anti-diabetic drugs or insulin), and laboratuary parameters of within 24 hours of admission (levels of white blood cell (WBC), lymphocyte neutrophil, hemoglobin (Hb), platelet, fasting glucose, glycated hemoglobin, aspartate aminotransferase (AST) , c-reactive protein (CRP), ferritin, and procalcitonin) were recorded from medical records and collected by two trained fellow geriatricians.
Key inclusion criteria (1 listed)
- We included all hospitalized Covid-19 patients with diabetes mellitus according to the any established diagnosis prior to admission or American Diabetes Association guidelines for diagnostic criteria
Key exclusion criteria (1 listed)
- The patients with severe Covid-19 infection, secondary diabetes or type 1 diabetes mellitus were excluded.
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 |
|---|---|---|
| Inflamatory biomarkerslaboratuary parameters of within 24 hours of admission (levels of white blood cell (WBC), lymphocyte neutrophil, hemoglobin (Hb), platelet, fasting glucose, glycated hemoglobin, aspartate aminotransferase (AST) , c-reactive protein (CRP), ferritin, and procalcitonin) were recorded from medical records and collected by two trained fellow geriatricians. | Diagnostic test | Length of hospital Stay (normal), Length of hospital Stay (prolonged) |
Primary outcome
Prolonged Length of hospital
Time frame: at least 2 week
The primary outcome was hospital length of stay (LOS), which was calculated according to the number of days of hospitalization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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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.
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 Hospitalism and COVID-19 Pneumonia, run by Gulhane Training and Research Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bilal KATIPOGLU, MD (5543330380, drbilal07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged Length of hospital (time frame: at least 2 week). 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 23 Sep 2021.