The Effect of Diabetes Mellitus on Mortality of Patients... | NCT04663659

Studies
The Effect of Diabetes Mellitus on Mortality of Patients With COVID-19

NCT04663659

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Status

Completed

Last Update Posted

Dec 14, 2020Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Covid19
Diabetes Mellitus

Interventions

no intervention

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2020Actual

Primary Completion Date

May 15, 2020Actual

Completion Date

May 15, 2020Actual

First Submitted Date

Dec 10, 2020

First Submission Date that Met QC Criteria

Dec 10, 2020

First Posted Date

Dec 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2020

Last Update Posted Date

Dec 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nermin Balta Başı, medical doctor, Sisli Hamidiye Etfal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Sisli Hamidiye Etfal Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.

Retrospective records were examined by examining the electronic data files of the patients.

Polymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.

Patients over 18 years of age with and without a medical history of DM in their history were identified and compared in 2 groups.

Detailed Description

The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.

Retrospective records will be examined by examining the electronic data files of the patients.

Patients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups.

Demographic data such as age, gender, Body Mass Index (BMI) of all patients, presence of additional comorbid disease, blood glucose values during hospitalization in intensive care, ferritin, C-Reactive Protein (CRP), respiratory support methods (nasal oxygen, nasal high flow, non-invasive mechanical ventilation, intubation), length of stay in intensive care unit, and mortality will be recorded.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
diabetic group		Patients over the age of 18 with diabetes mellitus in intensive care unit	Other: no intervention
non-diabetic group		Patients over the age of 18 without diabetes mellitus in intensive care unit	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	diabetic group non-diabetic group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Mortality rates of patients	3 months
length of stay in intensive care	The time between admission to intensive care unit and discharge	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients over 18 years of age

Exclusion Criteria:

Patients under 18 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nermin Balta Basi	Sisli Hamidiye Etfal Education and Training Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SisliHamidiye Etfal Education and Training Hospital		Istanbul		34771	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided