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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040592
Receipt No. R000046328
Scientific Title Retrospective cohort study of skin-to-renal pelvis distance in the patient with acute focal bacterial nephritis
Date of disclosure of the study information 2020/06/01
Last modified on 2020/11/28

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Basic information
Public title Retrospective cohort study of skin-to-renal pelvis distance in the patient with acute focal bacterial nephritis
Acronym Retrospective cohort study of skin-to-renal pelvis distance in the patient with acute focal bacterial nephritis
Scientific Title Retrospective cohort study of skin-to-renal pelvis distance in the patient with acute focal bacterial nephritis
Scientific Title:Acronym Retrospective cohort study of skin-to-renal pelvis distance in the patient with acute focal bacterial nephritis
Region
Japan

Condition
Condition acute focal bacterial nephritis
Classification by specialty
Medicine in general Infectious disease Urology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the value of skin-to-renal pelvis distance for detection of costvertebral angle knock pain in patients with acute focal bacterial nephritis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes presence of costovertebral angle knock pain on admission
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We retrospectively reviewed the charts of the patients diagnosed with AFBN between April 2013 and June 2019 in our hospital. Diagnosis of AFBN was based on ultrasound or CT with contrast revealing one or more wedge-shaped areas of decreased vascularity and confirmation that the fever could not be clinically attributed to another condition.
Key exclusion criteria We excluded patients with kidney stones and those with abnormally large or small kidneys (kidneys smaller than or larger than 9-14 cm).
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Kaneko
Organization Akashi medical center
Division name Department of General Internal Medicine
Zip code 674-0063
Address 743-33, Yagi, Ohkubo-cho, Akashi City, Hyogo Prefecture
TEL 0789361101
Email qhnqj628@gmail.com

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Kaneko
Organization Akashi medical center
Division name Department of General Internal Medicine
Zip code 674-0063
Address 743-33, Yagi, Ohkubo-cho, Akashi City, Hyogo Prefecture
TEL 0789361101
Homepage URL
Email qhnqj628@gmail.com

Sponsor
Institute Akashi medical center
Institute
Department

Funding Source
Organization no funding source
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 Akashi medical center
Address 743-33, Yagi, Ohkubo-cho, Akashi City, Hyogo Prefecture
Tel 0789361101
Email qhnqj628@gmail.com

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 明石医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2020 Year 06 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 23
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 No longer recruiting
Date of protocol fixation
2019 Year 06 Month 01 Day
Date of IRB
2019 Year 06 Month 24 Day
Anticipated trial start date
2019 Year 06 Month 24 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 04 Month 01 Day

Other
Other related information Receiver operating characteristic curve were drawn to evaluate discriminability of each variable, including skin-to-renal pelvis distance. Logistic regression analysis was also performed with costovertebral angle knock knock pain as a dependent variable, and skin-to-renal pelvis distance, and other clinical parameter as explanatory variables.

Management information
Registered date
2020 Year 05 Month 30 Day
Last modified on
2020 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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