UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057769 |
|---|---|
| Receipt number | R000066019 |
| Scientific Title | Investigation of the long-term reno-protective effect of amino acid administration on cardiovascular surgery-associated acute kidney injury. |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/05/03 17:32:56 |
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Basic information
Public title
Investigation of the long-term reno-protective effect of amino acid administration on cardiovascular surgery-associated acute kidney injury.
Acronym
Investigation of the long-term reno-protective effect of amino acid administration on cardiovascular surgery-associated acute kidney injury.
Scientific Title
Investigation of the long-term reno-protective effect of amino acid administration on cardiovascular surgery-associated acute kidney injury.
Scientific Title:Acronym
Investigation of the long-term reno-protective effect of amino acid administration on cardiovascular surgery-associated acute kidney injury.
Region
| Japan |
Condition
Condition
Thoracic or thoracoabdominal aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reno-protective effect of amino acid administration on renal function and mortality in the remote postoperative period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum creatinine level and eGFR at 1 year postoperatively
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 and Female
Key inclusion criteria
1) Patients undergoing thoracic or thoracoabdominal aortic replacement surgery
2) Patients who are 20 years of age or older at the time of consent
3) Patients scheduled to enter the ICU after surgery
4) Patients who have given their written consent
Key exclusion criteria
Patients who refused to participate in this study
Target sample size
66
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 critical care medicine
Zip code
564-8565
Address
6-1 Kishibe Shinmachi, Suita, Osaka, Japan
TEL
0570-012-545
k.minami@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kimito |
| Middle name | |
| Last name | Minami |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of critical care medicine
Zip code
564-8565
Address
6-1 Kishibe Shinmachi, Suita, Osaka, Japan
TEL
0570-012-545
Homepage URL
k.minami@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
6-1 Kishibe Shinmachi, Suita, Osaka, Japan
Tel
0570-012-545
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
| 2025 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In a single-center, observational study of patients who participated in the clinical study, "Prevention of cardiovascular surgery-associated acute kidney injury by amino acid administration: a single-center, single-blind, randomized controlled trial," the relationship between perioperative amino acid administration and creatinine levels, estimated glomerular filtration rate, and new-onset dialysis dependence at 1 year postoperatively will be clarified.
Management information
Registered date
| 2025 | Year | 05 | Month | 03 | Day |
Last modified on
| 2025 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066019
