UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000040482
Receipt No. 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 (Ver. 4)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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
Email 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
Email sy.hospitalist.japan@gmail.com

Sponsor
Institute Department of General Medicine, Saga University Hospital, Japan
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046206