UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prevalence of acute kidney injury in trauma patients admitted in an intensive care unit: a prospective observational study.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Jun Fujinaga
Organization	Kurashiki Central Hospital
Division name	Department of emergency medicine
Address	1-1-1 Miwa Kurashiki Okayama Japan.
TEL	+81-86-422-0210
Email	jf13594@kchnet.or.jp

Public contact
Name of contact person	Jun Fujinaga
Organization	Kurashiki Central Hospital
Division name	Department of emergency medicine
Address	1-1-1 Miwa Kurashiki Okayama, Japan
TEL	+81-86-422-0210
Homepage URL
Email	jf13594@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016690