UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044097
Receipt number 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 2023/01/21 23:58:13

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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

Department of General Internal Medicine

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 or person

Institute

Akashi Medical Center

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

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

Completed

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

2023 Year 01 Month 21 Day



Link to view the page

Value
https://center6.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