UMIN-CTR Clinical Trial

Basic information
Public title	Preoperative renal function affects perioperative AKI and CKD in lower GI surgery
Acronym	preoperative renal function and CKD
Scientific Title	Preoperative renal function affects perioperative AKI and CKD in lower GI surgery
Scientific Title:Acronym	preoperative renal function and CKD
Region	Japan

Condition
Condition	gastrointestinal disease
Classification by specialty	Gastrointestinal surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The incidence of AKI to CKD is higher in patient with AKI than in patient without AKI on lower gastrointestinal surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the incidence of chronic kidney disease for 2year after surgery
Key secondary outcomes	the incidence of post operative acute kidney injury

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	Patient who were underwent lower gastrointestinal surgery
Key exclusion criteria	patient who treated with hemodialysis
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Tateda
Organization	Kawasaki Munucipal Tama Hospital
Division name	Anesthesiology
Zip code	194-0201
Address	1-30-37, Syukugawara Tama-ku Kawasaki, Kanagawa
TEL	0449338111
Email	t2tateda@marianna-u.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Tateda
Organization	Kawasaki Munucipal Tama Hospital
Division name	Anesthesiology
Zip code	194-0201
Address	1-30-37, Syukugawara Tama-ku Kawasaki, Kanagawa
TEL	0449338111
Homepage URL
Email	t2tateda@marianna-u.ac.jp

Sponsor
Institute	Department of Anesthesiology Kawasaki Municipal Tama Hospital
Institute
Department

Funding Source
Organization	Kawasaki Municipal Tama Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St. Marianna University School of Medicine
Address	2-16-1, Sugao, Miyamae, Kawasaki
Tel	0449778111
Email	k-sienbu.mail@marianna-u.ac.jp

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	2018 Year 10 Month 01 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	2018 Year 07 Month 31 Day
Date of IRB	2018 Year 10 Month 04 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 04 Month 01 Day
Date trial data considered complete	2019 Year 05 Month 01 Day
Date analysis concluded	2019 Year 05 Month 15 Day

Other
Other related information	Patients who underwent lower GI surgery between 2013 and 2017. Two years follow up. Patient background,intraoperative and postoperative variables were compared with preoperative kidney function. The logistic regression and Cox regression analysis are used to determine predictive factor of CKD.

Management information
Registered date	2018 Year 08 Month 02 Day
Last modified on	2019 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=R000038325