UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041344 |
|---|---|
| Receipt number | R000047202 |
| Scientific Title | Development of prediction rule of infective endocarditis to fever of unknown origin: A single-hospital-based case-control study |
| Date of disclosure of the study information | 2020/08/07 |
| Last modified on | 2022/04/28 10:50:15 |
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Basic information
Public title
Development of prediction rule of infective endocarditis to fever of unknown origin: A single-hospital-based case-control study
Acronym
Development of prediction rule of infective endocarditis to fever of unknown origin: A single-hospital-based case-control study
Scientific Title
Development of prediction rule of infective endocarditis to fever of unknown origin: A single-hospital-based case-control study
Scientific Title:Acronym
Clinical prediction rule of infective endocarditis
Region
| Japan |
Condition
Condition
Infective endocarditis/fever of unknown origin
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Cardiology |
| Pneumology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Nephrology | Neurology | Clinical immunology |
| Infectious disease | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Dermatology | Urology | Emergency medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop clinical prediction rule of definite IE in modified Dukes criteria for fever of unknown origin, comparing inpatients with IE and inpatients with fever of unknown origin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Modified Dukes criteria
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with ICD-10 code of IE (I-330) admitted to our hospital from September 2007 to August 2017
3. Patients with ICD-10 code of fever of unknown origin (R-50-9) admitted to our hospital from January 2015 to December 2017
Key exclusion criteria
1. Non-hospitalization
2. Without fever before hospitalization
3. Of I-330 patients, nosocomial onset patients or non-definite IE in modified Dukes criteria
4. Of patients with I-330, patients with referral for valve surgery after treatment in previous hospital
5. Of patients with R-50-9, patients with identifiable fever origin before hospitalization
6. Those who have announced that they will not participate in the research
Target sample size
100
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 | Masaki |
| Middle name | |
| Last name | Tago |
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
https://www.hospital.med.saga-u.ac.jp/chiken/patient/open/general.html
tagomas@cc.saga-u.ac.jp
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 | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
144
Results
Results date posted
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
| 2020 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 10 | Month | 26 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 26 | Day |
Other
Other related information
Three doctors of the general medical department of our hospital checked the referral letter from the previous doctor and the medical information in the electronic medical record, and collected the data on potentially eligible patients. The survey items are age, sex, length of hospital stay, presence of death within 30 days after admission, presence of death during hospitalization, presence of emergency transportation, presence of pre-hospital antibiotics, and symptoms within 2 months of visiting our hospital ( respiratory distress, consciousness disorder, paralysis, weakness, general malaise, back pain, arthralgia), comorbidities and their nature (chronic skin disease, diabetes, malignant tumor, administration of steroids or immunosuppressants, chronic renal failure, vasculitis, history of a dental clinic visit within the past six months, history of invasive dental treatments within the past six months), Vital sign at admission (pulse rate, respiratory rate, systolic blood pressure, diastolic blood pressure, SpO2, consciousness disorder, oxygen use, oxygen dose), physical examinations on admission (cardiac murmur or dental lesions), laboratory findings on admission, and chest imaging findings within 14 days after admission (pulmonary edema or pleural effusion).
Management information
Registered date
| 2020 | Year | 08 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047202
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/05/13 | IE予測；Data base（UMIN登録用）.xlsx |
