UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038527 |
|---|---|
| Receipt number | R000041797 |
| Scientific Title | An observational study of renal protection by intravenous amino acid therapy in abdominal aortic aneurysm surgery |
| Date of disclosure of the study information | 2019/11/11 |
| Last modified on | 2023/05/29 13:40:39 |
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Basic information
Public title
An observational study of renal protection by intravenous amino acid therapy in abdominal aortic aneurysm surgery
Acronym
An observational study of renal protection by intravenous amino acid therapy in abdominal aortic aneurysm surgery
Scientific Title
An observational study of renal protection by intravenous amino acid therapy in abdominal aortic aneurysm surgery
Scientific Title:Acronym
An observational study of renal protection by intravenous amino acid therapy in abdominal aortic aneurysm surgery
Region
| Japan |
Condition
Condition
abdominal aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of postoperative renal protection by intravenous amino acid therapy for abdominal aortic aneurysm surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative serum creatinine
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
preoperative estimate glomerular filtration rate >=15ml/min/1.73m^2
Key exclusion criteria
none
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kimito |
| Middle name | |
| Last name | Minami |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Surgical Intensive Care
Zip code
564-8565
Address
6-1, Kishibeshinmachi, Suita, Osaka
TEL
06-6170-1070
k.minami@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kazawa |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of anesthesiology
Zip code
564-8565
Address
6-1, Kishibeshinmachi, Suita, Osaka
TEL
06-6170-1070
Homepage URL
kazawa.masahiro@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
Department of anesthesiology
Tel
06-6170-1070
rec-office-ac@ncvc.go.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
| 2019 | Year | 11 | Month | 11 | 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
2000
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
| 2019 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 11 | Month | 01 | Day |
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041797
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
