UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024923
Receipt number 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 12:38:27

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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 or person

Institute

Kyoto University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028671