UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prognosis of acute kidney injury after major abdominal surgery
Title of the study (Brief title)	Acute kidney injury after abdominal surgery
Region	Japan

Condition
Condition	patients who underwent major abdominal surgery
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to determine perioperative risk factor andprognosis of acute kidney injury after major abdominal surgery
Basic objectives2	Others
Basic objectives -Others	association between postoperative chronic kidney disease and acute kidney injury
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	incidence of acute kidney injury and chronic kidney disease
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients who underwent major abdominal surgery
Key exclusion criteria	chronic kidney disease
Target sample size	1000

Research contact person
Name of lead principal investigator	Morita Saori
Organization	Kawasaki Municipal Tama Hospital
Division name	Anesthesiology
Address	1-30-37, Syukugawara, Tama-ku, Kawasaki
TEL	044(933)8111
Email	saori-m@marianna-u.ac.jp

Public contact
Name of contact person	Tateda Takeshi
Organization	Kawasaki Municipal Tama Hospital
Division name	Anesthesiology
Address	1-30-37, Syukugawara, Tama-ku, Kawasaki
TEL	044(933)8111
Homepage URL
Email	t2tateda@marianna-u.ac.jp

Sponsor
Institute	Kawasaki Municipal Tama Hospital
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine
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	川崎市立多摩病院

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 10 Day
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 05 Month 15 Day
Date analysis concluded	2018 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Predictor of CKD are preoperative renalfunction (OR:0.92),cancer surgery (OR:8.93),AKI (OR10.9).
Other related information	Cohort study retrospective study Between June 1, 2013 and December 31, 2015

Management information
Registered date	2017 Year 11 Month 16 Day
Last modified on	2018 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034264