UMIN-CTR Clinical Trial

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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