UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014340
Receipt number R000016690
Scientific Title The prevalence of acute kidney injury in trauma patients admitted in an intensive care unit: a prospective observational study.
Date of disclosure of the study information 2014/06/23
Last modified on 2016/06/30 16:09:37

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Basic information

Public title

The prevalence of acute kidney injury in trauma patients admitted in an intensive care unit: a prospective observational study.

Acronym

The prevalence of acute kidney injury in trauma patients admitted in an intensive care unit: a prospective observational study.

Scientific Title

The prevalence of acute kidney injury in trauma patients admitted in an intensive care unit: a prospective observational study.

Scientific Title:Acronym

The prevalence of acute kidney injury in trauma patients admitted in an intensive care unit: a prospective observational study.

Region

Japan


Condition

Condition

Trauma patients admitted to the intensive care unit in a tertiary care hospital.

Classification by specialty

Emergency medicine Intensive care medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the prevalence of acute kidney injury (AKI) in trauma patients that required admissions to the ICU in a tertiary care hospital.

Basic objectives2

Others

Basic objectives -Others

To elucidate the risk of incident AKI and its prognosis.

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

1)Occurrence of AKI
2)Outcomes at day 28 and at discharge
3)Length of ICU stay and hospital stay.

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

Trauma patients visited our hospital and admitted to our emergency ICU.

Key exclusion criteria

Patients discharged from the emergency department.
Patients died in the ED.
Patients required only palliative care on admission.
Patients undergoing maintenance hemodialysis.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Fujinaga

Organization

Kurashiki Central Hospital

Division name

Department of emergency medicine

Zip code


Address

1-1-1 Miwa Kurashiki Okayama Japan.

TEL

+81-86-422-0210

Email

jf13594@kchnet.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jun Fujinaga

Organization

Kurashiki Central Hospital

Division name

Department of emergency medicine

Zip code


Address

1-1-1 Miwa Kurashiki Okayama, Japan

TEL

+81-86-422-0210

Homepage URL


Email

jf13594@kchnet.or.jp


Sponsor or person

Institute

Kurashiki Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Kurashiki Central Hospital

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


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

倉敷中央病院(岡山県)
Kurashiki Central Hospital


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 23 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

2014 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 01 Day

Last follow-up date

2016 Year 12 Month 31 Day

Date of closure to data entry

2016 Year 12 Month 31 Day

Date trial data considered complete

2016 Year 12 Month 31 Day

Date analysis concluded



Other

Other related information

prospective observational study


Management information

Registered date

2014 Year 06 Month 23 Day

Last modified on

2016 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016690


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name