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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033608
Receipt No. R000038325
Scientific Title Preoperative renal function affects perioperative AKI and CKD in lower GI surgery
Date of disclosure of the study information 2018/10/01
Last modified on 2019/08/02

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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