UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005855 |
|---|---|
| Receipt number | R000006914 |
| Scientific Title | A study on evaluation of renal function of transplantationed kidney, and safety and efficacy of total intravenous anesthesia in renal transplantation |
| Date of disclosure of the study information | 2011/06/29 |
| Last modified on | 2019/12/03 11:28:22 |
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Basic information
Public title
A study on evaluation of renal function of transplantationed kidney, and safety and efficacy of total intravenous anesthesia in renal transplantation
Acronym
Total intravenous anesthesia in renal transplantation
Scientific Title
A study on evaluation of renal function of transplantationed kidney, and safety and efficacy of total intravenous anesthesia in renal transplantation
Scientific Title:Acronym
Total intravenous anesthesia in renal transplantation
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Medicine in general | Nephrology | Surgery in general |
| Anesthesiology | Intensive care medicine | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to evaluate renal function of transplantationed kidney, and safety and efficacy of total intravenous anesthesia in renal transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Renal function of transplanted kidney, and safety and efficacy of total intravenous anesthesia in renal transplantation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Recipient
from Jun. 28, 2011 to Dec. 31, 2016
blood sample 9ml
12 times
Interventions/Control_2
Control
from Jun. 28, 2011 to Dec. 31, 2016
blood sample 9ml
12 times
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will have renal transplantation at Hirosaki University Hospital, who has informed consent to this study. Patients who will have a surgery with general anesthesia including living donor of renal transplantation at Hirosaki University Hospital, who has informed consent to this study.
Key exclusion criteria
Patients who will have renal transplantation at Hirosaki University Hospital, who do not have informed consent to this study. Patients who will have a surgery with general anesthesia including living donor of renal transplantation at Hirosaki University Hospital, who do not have informed consent to this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kushikata |
Organization
Hirosaki University
Division name
Department of Anesthesiology, Graduate School of Medicine
Zip code
0368563
Address
Zaifu 5, Hirosaki, Aomori
TEL
0172335113
tetsuyak@cc.hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kushikata |
Organization
Hirosaki University
Division name
Department of Anesthesiology, Graduate School of Medicine
Zip code
0368562
Address
Zaifu 5, Hirosaki, Aomori
TEL
0172335113
Homepage URL
tetsuyak@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Hospital
Address
honcho 53, Hirosaki, JAPAN
Tel
0172335111
tetsuyak@hirosaki-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
| 2011 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
still on the analysis data obtained. the data include blood level of ketamine and its half life.
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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 27 | Day |
Last modified on
| 2019 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006914
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
