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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044097
Receipt No. R000050357
Scientific Title Bacteremia in diabetic ketoacidosis patients: a retrospective cohort study
Date of disclosure of the study information 2021/05/03
Last modified on 2021/05/03

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Basic information
Public title Bacteremia in diabetic ketoacidosis patients: a retrospective cohort study
Acronym Bacteremia in diabetic ketoacidosis patients
Scientific Title Bacteremia in diabetic ketoacidosis patients: a retrospective cohort study
Scientific Title:Acronym Bacteremia in diabetic ketoacidosis patients
Region
Japan

Condition
Condition diabetes ketoacidosis
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study aimed to determine the rate of
bacteremia in patients with diabetic ketoacidosis (DKA).
Basic objectives2 Others
Basic objectives -Others To investigate the factors associated with the positive blood culture.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the rate of bacteremia
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients aged more than and equal to 18
years who visited emergency department in Akashi medical center with a diagnosis of DKA and HHS between Jan 1, 2008 and December 31, 2020
Key exclusion criteria Those without demographic data, evidence of ketosis, plasma glucose, bicarbonate, pH or plasma osmolarity.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Naoto
Middle name
Last name Ishimaru
Organization Akashi Medical Center
Division name Department of General Internal Medicine
Zip code 6740063
Address Akashi
TEL 0789361101
Email maru-tkb@umin.ac.jp

Public contact
Name of contact person
1st name Naoto
Middle name
Last name Ishimaru
Organization Akashi Medical Center
Division name Akashi Medical Center
Zip code 6740063
Address 743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL 0789361101
Homepage URL
Email maru-tkb@umin.ac.jp

Sponsor
Institute Akashi Medical Center
Institute
Department

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 Akashi Medical Center
Address 743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
Tel 0789361101
Email yokoyama.naoki@aijinkai-group.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

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 03 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
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 Enrolling by invitation
Date of protocol fixation
2021 Year 05 Month 03 Day
Date of IRB
2021 Year 05 Month 06 Day
Anticipated trial start date
2021 Year 05 Month 06 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Demographic data, the presence of bacteremia, blood pressure, pH, plasma glucose, bicarbonate level and plasma osmolarity were obtained from patient's charts.

Management information
Registered date
2021 Year 05 Month 03 Day
Last modified on
2021 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050357

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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