UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040592 |
|---|---|
| Receipt number | 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 | 2023/01/17 10:30:58 |
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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
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
qhnqj628@gmail.com
Sponsor or person
Institute
Akashi medical center
Institute
Department
Personal name
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
maru-tkb@umin.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
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
no release
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36578113/
Number of participants that the trial has enrolled
23
Results
CVA tenderness was present in 8 of these 23 patients. ROC curves were drawn to evaluate the ability to differentiate skin-to-renal pelvis distance (SPD), body mass index, and age. Only SPD was a useful predictor of CVA tenderness, and 66 mm was determined as the optimal cutoff point (area under the receiver operating characteristic curve 0.858, 95% confidence interval 0.70-1.00).
Results date posted
| 2023 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
retrospectively reviewed the charts of our patients between April 2013 and June 2019 who were diagnosed as having AFBN
Participant flow
retrospective charts review
Adverse events
no adverse events because of retrospective cohort design
Outcome measures
distance between the skin and the renal pelvis affects the detection of costovertebral angle (CVA) tenderness in patients with acute focal bacterial nephritis (AFBN).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 01 | Day |
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
| 2023 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046328
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