UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033608 |
|---|---|
| Receipt number | 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 12:28:18 |
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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
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
t2tateda@marianna-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology
Kawasaki Municipal Tama Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038325
