NCT05054283

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

September 14, 2021

Last Update Submit

September 14, 2021

Conditions

Keywords

Length of hospital stayCovid-19 PneumoniaDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Prolonged Length of hospital

    The primary outcome was hospital length of stay (LOS), which was calculated according to the number of days of hospitalization.

    at least 2 week

Study Arms (2)

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.

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.

Diagnostic Test: Inflamatory biomarkers

Interventions

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.

Length of hospital Stay (normal)Length of hospital Stay (prolonged)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • The patients with severe Covid-19 infection, secondary diabetes or type 1 diabetes mellitus were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane training and research hospital

Ankara, 06670, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Bilal KATIPOGLU, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Geriatrics

Study Record Dates

First Submitted

September 14, 2021

First Posted

September 23, 2021

Study Start

October 1, 2021

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations