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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024923
Receipt No. R000028671
Scientific Title Diagnosis, Risk Factors, and Mortality of Patients with Acute Kidney Injury in Japanese Intensive Care Units
Date of disclosure of the study information 2016/11/21
Last modified on 2017/11/22

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Basic information
Public title Diagnosis, Risk Factors, and Mortality of Patients with Acute Kidney Injury in Japanese Intensive Care Units
Acronym the JAKID study
Scientific Title Diagnosis, Risk Factors, and Mortality of Patients with Acute Kidney Injury in Japanese Intensive Care Units
Scientific Title:Acronym the JAKID study
Region
Japan

Condition
Condition Adult patients admitted to the ICU
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the proportion of AKI diagnosis, risk factors and outcome of AKI in Japanese critically ill patients.
Basic objectives2 Others
Basic objectives -Others Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hospital mortality
Key secondary outcomes ICU length of stay
ICU mortality
Limitation of medical therapy
Hospital length of stay
Renal replacement therapy during ICU stay
Duration of renal replacement therapy
Renal replacement therapy dependence at hospital discharge
Creatinine levels at hospital discharge

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 Critically ill patients admitted to the ICU.
Key exclusion criteria Under 18 years of age
ICU stay < 24 hours
Renal replacement therapy before ICU admission, including chronic dialysis
Admission after kidney surgery
History of urinary diversion
Refusal of participation
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Fujii
Organization Kyoto University
Division name Graduate School of Medicine
Zip code
Address Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL 075-753-2431
Email tofujii-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Fujii
Organization Kyoto University
Division name Graduate School of Medicine
Zip code
Address Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL 075-753-2431
Homepage URL http://jakid.sakura.ne.jp/
Email tofujii-tky@umin.net

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 21 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
2016 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design and setting: A multicenter prospective observational study in the Japanese ICUs.

Registration: Consecutively all eligible patients admitted to the ICU.

Variables:
Patient demographics -age, gender, height, weight, route, readmission, baseline creatinine levels, etc.
Daily data -arterial pressure, GCS, respiratory support, laboratory data, urine output, renal replacement therapy, vasopressors, etc.
Outcome data -ICU length of stay hospital length of stay, renal replacement therapy during hospital stay, etc.


Management information
Registered date
2016 Year 11 Month 21 Day
Last modified on
2017 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028671

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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