UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025934 |
|---|---|
| Receipt number | R000029818 |
| Scientific Title | The relationship between perioperative acute kidney injury and biomakers in robot-assisted laparoscopic prostatectomy |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2017/01/31 21:44:42 |
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Basic information
Public title
The relationship between perioperative acute kidney injury and biomakers in robot-assisted laparoscopic prostatectomy
Acronym
The relationship between perioperative acute kidney injury and biomakers in robot-assisted laparoscopic prostatectomy
Scientific Title
The relationship between perioperative acute kidney injury and biomakers in robot-assisted laparoscopic prostatectomy
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tatsuyuki Kurashiki |
Organization
Tottori University
Division name
Division of Anesthesiology and Critical Care Medicine
Zip code
Address
36-1, Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6657
takurashiki@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuyuki Kurashiki |
Organization
Tottori University
Division name
Division of Anesthesiology and Critical Care Medicine
Zip code
Address
36-1, Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6657
Homepage URL
takurashiki@med.tottori-u.ac.jp
Sponsor or person
Institute
Division of Anesthesiology and Critical Care Medicine, Tottori University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 06 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029818
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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