UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015704 |
|---|---|
| Receipt number | R000018256 |
| Scientific Title | Investigation of risk factors for perioperative acute kidney injury after robot-assisted laparoscopic radical prostatectomy (RALP) |
| Date of disclosure of the study information | 2014/11/25 |
| Last modified on | 2015/06/29 20:01:16 |
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Basic information
Public title
Investigation of risk factors for perioperative acute kidney injury after robot-assisted laparoscopic radical prostatectomy (RALP)
Acronym
Investigation of risk factors for perioperative acute kidney injury after robot-assisted laparoscopic radical prostatectomy (RALP)
Scientific Title
Investigation of risk factors for perioperative acute kidney injury after robot-assisted laparoscopic radical prostatectomy (RALP)
Scientific Title:Acronym
Investigation of risk factors for perioperative acute kidney injury after robot-assisted laparoscopic radical prostatectomy (RALP)
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of postoperative acute kidney injury (AKI), define the risk factors for AKI, and clarify the relationships between AKI and outcome during hospitalization.
Basic objectives2
Others
Basic objectives -Others
epidemiology research
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
risk factors, incidence rate, outcome
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
Key inclusion criteria
patients who underwent robot-assisted laparoscopic prostatectomy (RALP)
Key exclusion criteria
1.hemodialysis dependent patients
2.patients who required additional surgery within 72 hours postoperatively
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumi Funaki |
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
funapon1116@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Funaki |
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
funapon1116@gmail.com
Sponsor or person
Institute
Division of Anesthesiology and Critical Care Medicin, 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
鳥取大学医学部附属病院（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 25 | 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
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who underwent robot-assisted laparoscopic prostatectomy (RALP) from Oct 1, 2010 and Sep 30, 2014 at Tottori University Hospital are enrolled. The incidence of perioperative acute kidney injury (AKI) will be calculated, the risk factors will be defined, and the relationships between AKI and outcome will be clarified.
Management information
Registered date
| 2014 | Year | 11 | Month | 16 | Day |
Last modified on
| 2015 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018256
