UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between perioperative acute kidney injury and biomakers in robot-assisted laparoscopic prostatectomy
Title of the study (Brief title)	The relationship between perioperative acute kidney injury and biomakers in robot-assisted laparoscopic prostatectomy
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Urology Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We examine the relationship between perioperative acute kidney injury (AKI) and biomakers of AKI in robot-assisted laparoscopic prostatectomy (RALP).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The relationship between perioperative AKI and biomarkers
Key secondary outcomes	1.risk factors for AKI 2.the relationship between AKI and the following items: (1)hospital mortality, postoperative day 28 mortality, postoperative day 90 mortality (2)length of ICU stay, ventilator free day (3)Incidence of the postoperative infection (4)Incidence of the postoperative complication

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1)patients scheduled for RALP 2)patients who are able to obtain consent
Key exclusion criteria	1)patient with dementia and psychosis 2)patients whom research investigator has determined to be inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	Tatsuyuki Kurashiki
Organization	Tottori University
Division name	Division of Anesthesiology and Critical Care Medicine
Address	36-1, Nishi-cho, Yonago, Tottori, Japan
TEL	0859-38-6657
Email	takurashiki@med.tottori-u.ac.jp

Public contact
Name of contact person	Tatsuyuki Kurashiki
Organization	Tottori University
Division name	Division of Anesthesiology and Critical Care Medicine
Address	36-1, Nishi-cho, Yonago, Tottori, Japan
TEL	0859-38-6657
Homepage URL
Email	takurashiki@med.tottori-u.ac.jp

Sponsor
Institute	Division of Anesthesiology and Critical Care Medicine, Tottori University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 01 Month 31 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 06 Day
Anticipated trial start date	2017 Year 01 Month 31 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	Prospective observational study to investigate the relationship between perioperative acute kidney injury (AKI) and biomakers of AKI in robot-assisted laparoscopic prostatectomy (RALP).

Management information
Registered date	2017 Year 01 Month 31 Day
Last modified on	2017 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029818