UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnosis, Risk Factors, and Mortality of Patients with Acute Kidney Injury in Japanese Intensive Care Units
Title of the study (Brief title)	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	Tomoko Fujii
Organization	Kyoto University
Division name	Graduate School of Medicine
Address	Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL	075-753-2431
Email	tofujii-tky@umin.net

Public contact
Name of contact person	Tomoko Fujii
Organization	Kyoto University
Division name	Graduate School of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028671