UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040482 |
|---|---|
| Receipt number | R000046206 |
| Scientific Title | Status quo of diagnostic procedures and treatment of inpatients with infective endocarditis at the department of general medicine at a university hospital in a suburban city in Japan: a single-hospital-based retrospective study |
| Date of disclosure of the study information | 2020/05/21 |
| Last modified on | 2020/11/25 16:03:38 |
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Basic information
Public title
Status quo of diagnostic procedures and treatment of inpatients with infective endocarditis at the department of general medicine at a university hospital in a suburban city in Japan: a single-hospital-based retrospective study
Acronym
Status quo of diagnostic procedures and treatment of inpatients with infective endocarditis at the department of general medicine at a university hospital in a suburban city in Japan: a single-hospital-based retrospective study
Scientific Title
Status quo of diagnostic procedures and treatment of inpatients with infective endocarditis at the department of general medicine at a university hospital in a suburban city in Japan: a single-hospital-based retrospective study
Scientific Title:Acronym
Status quo of diagnostic procedures and treatment of inpatients with infective endocarditis at the department of general medicine
Region
| Japan |
Condition
Condition
infective endocarditis
Classification by specialty
| Medicine in general | Cardiology | Infectious disease |
| Ophthalmology | Radiology | Cardiovascular surgery |
| Operative medicine | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to clarify how the department of General Medicine in a University Hospital in a suburban city in Japan, Saga University Hospital, play a role in the diagnosis and treatment of IE, by comparing the characteristics of patients treated by the department of General Medicine to those only by the other departments including Cardiology and Cardiovascular Surgery.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
admission to the department of General Medicine
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inpatients diagnosed with IE in Saga University Hospital from 2007 to 2017 were identified from the International Statistical Classification of Diseases and Related Health Problems 10 code number I-330. Patients who were subsequently diagnosed as having definite IE according to modified Dukes clinical or pathological criteria were enrolled.
Key exclusion criteria
None
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Yamashita |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952343238
sy.hospitalist.japan@gmail.com
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Yamashita |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952343238
Homepage URL
sy.hospitalist.japan@gmail.com
Sponsor or person
Institute
Department of General Medicine, Saga University Hospital, Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of General Medicine, Saga University Hospital
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/status-quo-of-diagnostic-procedures-and-treatment-of-inpatients-with-i-pee
Number of participants that the trial has enrolled
74
Results
Seventy-four patients were included; 17 (23%) were admitted to the general medicine department. In the GM group, the percentage of patients diagnosed with definite or suspected IE was lower at preadmission. The GM group had higher percentages of patients with back or joint pain, pyogenic spondylitis, deep-seated abscesses, pyogenic arthritis and glomerulonephritis. Mortality within 30 days of admission to our hospital and overall in-hospital mortality did not significantly differ.
Results date posted
| 2020 | Year | 11 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Three doctors from the Department of General Medicine in our hospital checked the medical charts and collected data on potentially eligible patients. Survey items included age, sex, symptoms within 2 months before the first visit to our hospital, duration of hospitalization in our hospital, outcome on discharge, department to which the patient was admitted, transportation by ambulance or not, nosocomial infection or not, whether being diagnosed or suspected as IE before admission to our hospital or not, presence or absence of comorbidities and their nature, administration of steroids or immunosuppressants, presence or absence of antibiotics treatment prior to blood culture, presence or absence of dental disease on admission, history of a dental clinic visit within the past six months, history of invasive dental treatments within the past six months, all the laboratory and imaging studies performed during from the first visit to the previous hospital to the discharge from our hospital, valvular surgery for IE during this hospital stay or not, death within 30 days of admission to our hospital or not, presence or absence of death at any time during hospitalization, presence or absence of cardiac murmurs on admission, presence or absence of valvular disease on admission, type and grade of valvular disease on admission, causative microorganisms, the valve or valves infected, presence or absence of any complications and their nature, and the number of complications.
Management information
Registered date
| 2020 | Year | 05 | Month | 21 | Day |
Last modified on
| 2020 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046206
