UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042965 |
|---|---|
| Receipt number | R000049049 |
| Scientific Title | Development of a clinical prediction model for infective endocarditis among patients with undiagnosed fever: Multi-center based retrospective observational study. |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/07/24 12:47:18 |
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Basic information
Public title
Development of a clinical prediction model for infective endocarditis among patients with undiagnosed fever: Multi-center based retrospective observational study.
Acronym
Development of a clinical prediction model for infective endocarditis among patients with undiagnosed fever: Multi-center based retrospective observational study.
Scientific Title
Development of a clinical prediction model for infective endocarditis among patients with undiagnosed fever: Multi-center based retrospective observational study.
Scientific Title:Acronym
Clinical prediction model for infective endocarditis
Region
| Japan |
Condition
Condition
Infective endocarditis/fever of unknown origin
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Infectious disease | Geriatrics |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Dermatology |
| Urology | Radiology | Neurosurgery |
| Cardiovascular surgery | Laboratory medicine | Emergency medicine |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a clinical prediction model for definite Infective endocarditis among patients with undiagnosed fever in Saga University hospital, Juntendo University Hospital, Toho University Omori Medical Center, and Dokkyo Medical University Hospital.
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
Patients aged 20 years or older with ICD-10 code of I-330 (Infective endocarditis) or R-50-9 (undiagnosed fever) admitted to each hospital of research from January 2018 to December 2020.
Key exclusion criteria
1. Non-hospitalization
2. Without fever before hospitalization
3. Of I-330 patients, nosocomial onset patients, patients with referral for valve surgery after treatment in previous hospital and on-definite IE in modified Dukes criteria (DC).
4. Of patients with R-50-9, patients with identifiable fever origin before hospitalization and patients without chest x-ray, blood tests, and urinary tests before admission.
5. Patients with definite non-infectious disease despite modified DC being definite.
6. Those who have announced that they will not participate in the research
Target sample size
320
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
http://www.hospital.med.saga-u.ac.jp/chiken/
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
| 2021 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
320
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
| 2021 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multiple physicians collect the following medical information from medical records and referral letters from previous doctors.
Patient characteristics including patients ID, 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, 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 on admission including pulse rate, respiratory rate, systolic blood pressure, diastolic blood pressure, SpO2, consciousness disorder, oxygen dose.
Physical examinations on admission including cardiac murmur or dental lesions.
Chest imaging findings on admission including pulmonary edema or pleural effusion.
Laboratory findings on admission.
Items in modified Dukes criteria including blood culture, echocardiographic findings, past cardiac disease, fever over 38 degree, infarction, cranial bleeding, Roth spot, rheumatoid factor, or characteristic physical findings such as Osler node and Janeway lesion.
Management information
Registered date
| 2021 | Year | 01 | Month | 10 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049049
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
