UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053128 |
|---|---|
| Receipt number | R000060626 |
| Scientific Title | Intraoperative renal desaturation and postoperative acute kidney injury in patients undergoing robot-assisted laparoscopic radical prostatectomy |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/12/16 10:21:55 |
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Basic information
Public title
Intraoperative renal desaturation and postoperative acute kidney injury in patients undergoing robot-assisted laparoscopic radical prostatectomy
Acronym
Intraoperative renal desaturation and postoperative acute kidney injury in patients undergoing robot-assisted laparoscopic radical prostatectomy
Scientific Title
Intraoperative renal desaturation and postoperative acute kidney injury in patients undergoing robot-assisted laparoscopic radical prostatectomy
Scientific Title:Acronym
Intraoperative renal desaturation and postoperative acute kidney injury in patients undergoing robot-assisted laparoscopic radical prostatectomy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The object of this study is to investigate the association between decreased intraoperative renal tissue oxygen saturation and postoperative AKI in patients undergoing robot-assisted total prostatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative AKI
Key secondary outcomes
Length of hospital stay, postoperative dialysis induction rate, in-hospital mortality rate, 30-day postoperative mortality rate
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
Adult patients(Age>20)
Patients scheduled for elective robot-assisted total prostatectomy
Patients with consent
Key exclusion criteria
Age under 20
BMI>30kg/m2
renal depth > 4cm
Patients deemed unsuitable by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Niiyama |
Organization
Akita University Hospital
Division name
Department of Anesthesiology
Zip code
010-8543
Address
44-2 Hasunuma, Hiroomote , Akita City , Akita Prefecture
TEL
018-884-6175
niiyama@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Niiyama |
Organization
Akita University Hospital
Division name
Department of Anesthesiology
Zip code
010-8543
Address
44-2 Hasunuma, Hiroomote , Akita City , Akita Prefecture
TEL
018-884-6175
Homepage URL
niiyama@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Yukitoshi Niiyama
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
Certified Clinical Research Review Board Akita University
Address
44-2 Hasunuma, Hiroomote , Akita City , Akita Prefecture
Tel
018-834-1111
nintei@hos.akita-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design : Prospective cohort study
Recruitment method : During the study period, written explanations will be given to the relevant patients.
Management information
Registered date
| 2023 | Year | 12 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060626
